Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

NCT00271180 | Recruiting FDA Device

• 1 other identifier: 602
• Study Type: observational
• Target: 20,000
• Locations: 32 countries
• Sites: 309

Brief Summary

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Conditions

Arrhythmia; Bradycardia; Heart Failure; Sinus Tachycardia

Keywords

Cardiac Pacing; Implantable Cardioverter Defibrillator; pacemaker; Sinus Bradycardia

Outcome Measures

Primary Outcomes (1)

• Lead related complications for each lead model.

  All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.

  Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive).

Interventions

Device DEVICE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects implanted with Medtronic qualifying cardiac rhythm product.

You may not qualify if:

• Subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's IRB/MEC/REB
• AND one of the following must also apply:
• Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
• Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data
• Subjects who are, or will be inaccessible for follow-up
• Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
• Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Sponsors & Collaborators

• Medtronic: lead

Study Sites (318)

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Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Chandler, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Chula Vista, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Palm Springs, California, United States

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Rancho Mirage, California, United States

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Redwood City, California, United States

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Salinas, California, United States

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San Diego, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Van Nuys, California, United States

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Ventura, California, United States

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Aurora, Colorado, United States

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Centennial, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Lakewood, Colorado, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Clearwater, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Panama City, Florida, United States

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Safety Harbor, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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West Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Edgewood, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Clinton, Maryland, United States

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Hyattsville, Maryland, United States

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Salisbury, Maryland, United States

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Silver Spring, Maryland, United States

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Takoma Park, Maryland, United States

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Boston, Massachusetts, United States

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Lansing, Michigan, United States

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Marquette, Michigan, United States

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Ypsilanti, Michigan, United States

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Coon Rapids, Minnesota, United States

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Minneapolis, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Rochester, Minnesota, United States

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Saint Cloud, Minnesota, United States

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Saint Paul, Minnesota, United States

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Hattiesburg, Mississippi, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Eatontown, New Jersey, United States

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Marlton, New Jersey, United States

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Morristown, New Jersey, United States

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New Brunswick, New Jersey, United States

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Ocean City, New Jersey, United States

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Ridgewood, New Jersey, United States

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Albuquerque, New Mexico, United States

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Huntington, New York, United States

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Manhasset, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Utica, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Danville, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wilkes-Barre, Pennsylvania, United States

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Columbia, South Carolina, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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The Woodlands, Texas, United States

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Tyler, Texas, United States

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Burlington, Vermont, United States

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Charlottesville, Virginia, United States

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Falls Church, Virginia, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Chermside, Australia

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Douglas, Australia

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Murdoch, Australia

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Southport, Australia

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Graz, Austria

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Innsbruck, Austria

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Linz, Austria

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Vienna, Austria

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Bruges, Belgium

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Brussels, Belgium

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Edegem, Belgium

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Leuven, Belgium

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Liège, Belgium

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Yvoir, Belgium

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Calgary, Canada

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Kingston, Canada

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Montreal, Canada

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Québec, Canada

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Beijing, China

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Changsha, China

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Dalian, China

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Fuzhou, China

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Guangzhou, China

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Hangzhou, China

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Harbin, China

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Kunming, China

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Nanchang, China

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Shanghai, China

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Shantou, China

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Suzhou, China

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Taiyuan, China

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Tianjin, China

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Prague, Czechia

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Aarhus, Denmark

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Copenhagen, Denmark

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Hellerup, Denmark

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Hillerød, Denmark

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Odense, Denmark

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Helsinki, Finland

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Avignon, France

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Bayonne, France

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Brest, France

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Caen, France

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Chambray-lès-Tours, France

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Clermont-Ferrand, France

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Dijon, France

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La Rochelle, France

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La Tronche, France

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Lille, France

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Montpellier, France

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Nantes, France

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Neuilly-sur-Seine, France

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Paris, France

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Pessac, France

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Pringy, France

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Rennes, France

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Saint-Priest-en-Jarez, France

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Strasbourg, France

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Toulouse, France

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Vandœuvre-lès-Nancy, France

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Villeurbanne, France

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Aachen, Germany

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Bad Oeynhausen, Germany

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Bremen, Germany

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Cologne, Germany

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Dresden, Germany

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Düsseldorf, Germany

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Essen, Germany

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Hamburg, Germany

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Hanover, Germany

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Heidelberg, Germany

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Homburg, Germany

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Jena, Germany

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München, Germany

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Münster, Germany

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Tübingen, Germany

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Ulm, Germany

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Villingen-Schwenningen, Germany

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Athens, Greece

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Marousi, Greece

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Thessaloniki, Greece

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Hong Kong, Hong Kong

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Budapest, Hungary

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Reykjavik, Iceland

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Bangalore, India

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Gūrgaon, India

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Jaipur, India

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Kochi, India

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New Delhi, India

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Ashkelon, Israel

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Beersheba, Israel

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Jerusalem, Israel

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Ramat Gan, Israel

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Ancona, Italy

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Bari, Italy

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Bologna, Italy

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Brescia, Italy

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Castrovillari, Italy

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Cotignola, Italy

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Lecce, Italy

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Milan, Italy

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Monza, Italy

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Pisa, Italy

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Taranto, Italy

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Udine, Italy

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Ageo, Japan

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Bunkyō City, Japan

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Gifu, Japan

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Hidaka, Japan

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Hiroshima, Japan

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Kagoshima, Japan

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Kamakura, Japan

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Kawasaki, Japan

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Kitakyushu, Japan

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Koshigaya, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Mitaka, Japan

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Nagoya, Japan

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Niigata, Japan

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Okayama, Japan

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Ōsaka-sayama, Japan

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Sapporo, Japan

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Shinagawa-Ku, Japan

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Shizuoka, Japan

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Suita, Japan

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Tokyo, Japan

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Toyoake, Japan

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Tsukuba, Japan

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Urasoe, Japan

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Yamagata, Japan

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Yokohama, Japan

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Hadiya, Kuwait

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Kuwait City, Kuwait

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Kuala Lumpur, Malaysia

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Amsterdam, Netherlands

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Breda, Netherlands

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Eindhoven, Netherlands

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Enschede, Netherlands

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Groningen, Netherlands

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Leiden, Netherlands

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Maastricht, Netherlands

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Nieuwegein, Netherlands

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Rotterdam, Netherlands

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The Hague, Netherlands

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Christchurch, New Zealand

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Bergen, Norway

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Oslo, Norway

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Trondheim, Norway

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Poznan, Poland

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Warsaw, Poland

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Zabrze, Poland

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Carnaxide, Portugal

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Creixomil, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Santarém, Portugal

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Jeddah, Saudi Arabia

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Riyadh, Saudi Arabia

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Belgrade, Serbia

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Bratislava, Slovakia

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Košice, Slovakia

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Ljubljana, Slovenia

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Cheongju-si, South Korea

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Daejeon, South Korea

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Gyeonggi-do, South Korea

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Seoul, South Korea

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Suwon, South Korea

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A Coruña, Spain

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Barcelona, Spain

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Córdoba, Spain

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Girona, Spain

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Granada, Spain

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Madrid, Spain

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Palma de Mallorca, Spain

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Salamanca, Spain

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Santa Cruz de Tenerife, Spain

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Santiago de Compostela, Spain

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Toledo, Spain

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Valencia, Spain

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Valladolid, Spain

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Vitoria-Gasteiz, Spain

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Gothenburg, Sweden

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Lund, Sweden

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Skövde, Sweden

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Uppsala, Sweden

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Basel, Switzerland

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Bern, Switzerland

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Fribourg, Switzerland

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Geneva, Switzerland

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Lausanne, Switzerland

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Lugano, Switzerland

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Zurich, Switzerland

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Birmingham, United Kingdom

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Blackpool, United Kingdom

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Bristol, United Kingdom

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Leeds, United Kingdom

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Leicester, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Middlesbrough, United Kingdom

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Northampton, United Kingdom

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Nottingham, United Kingdom

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Sheffield, United Kingdom

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Southampton, United Kingdom

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MeSH Terms

Conditions

Arrhythmias, Cardiac; Bradycardia; Heart Failure; Tachycardia, Sinus

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Supraventricular; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Product Performance Report Study Leader

  Medtronic

  STUDY CHAIR

Central Study Contacts

Medtronic CRM Clinical Trials

CONTACT

medtroniccrmtrials@medtronic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2005
• First Posted: December 30, 2005
• Study Start: January 1, 1983
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

JP (27); SE (1); ES (14); CZ (1); CN (14); CH (7); AU (4); DE (17); US (112); IL (4); GB (13); NL (10); BE (6); SL (2); KU (2); NO (3); IT (12); FI (1); MY (1); PT (5); FR (22); IN (5); SA (2); KR (5); IC (1); PL (3); DK (5); HK (1); NZ (1); CA (4); GR (3); HU (1)