Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study

NCT02294331 | Completed

• 1 other identifier: Attain Performa™ PAS
• Study Type: observational
• Target: 1,900
• Locations: 8 countries
• Sites: 100

Brief Summary

Lead survivability will be summarized.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Lead complication

  Survival analysis will be used to analyze the lead. Lead status will be reported as a function of time post-implant for all leads in the study. Lead related complications include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.

  5 years

Secondary Outcomes (3)

• Types of lead-related adverse device effects

  5 years

• Returned lead analysis

  5 years

• Lead survival estimate by model

  5 years

Study Arms (1)

Attain Performa™ LV Leads

Patients who meet all Inclusion criteria and no Exclusion criteria and are implanted with an Attain Performa™ LV lead.

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

Patients implanted with an Attain Performa™ LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

You may not qualify if:

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Patient has or is intended to receive an Attain Performa™ LV lead
• Patient within 30 day post implant enrollment window
• Patient who is, or is expected to be inaccessible for follow-up
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Sponsors & Collaborators

• Medtronic: lead

Study Sites (100)

Unknown Facility

Birmingham, Alabama, 35294, United States

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Anchorage, Alaska, 99508, United States

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Chandler, Arizona, 85226, United States

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Gilbert, Arizona, 85295, United States

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Jonesboro, Arkansas, 72410, United States

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Bakersfield, California, 93301, United States

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Rancho Mirage, California, 92270, United States

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Redwood City, California, 94062, United States

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Salinas, California, 93901, United States

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San Diego, California, 92103, United States

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Stanford, California, 94305, United States

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Torrance, California, 90503, United States

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Van Nuys, California, 91405, United States

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Colorado Springs, Colorado, 80907, United States

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Lakewood, Colorado, 80228, United States

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New Haven, Connecticut, 06519, United States

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Washington D.C., District of Columbia, 20010, United States

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Bradenton, Florida, 34205, United States

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Clearwater, Florida, 33756, United States

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Jacksonville, Florida, 32216, United States

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Safety Harbor, Florida, 34695, United States

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Albany, Georgia, 31701, United States

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Marietta, Georgia, 30060, United States

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Evansville, Indiana, 47710, United States

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West Des Moines, Iowa, 50266, United States

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Kansas City, Kansas, 66160, United States

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Edgewood, Kentucky, 41017, United States

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Lexington, Kentucky, 40503, United States

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Louisville, Kentucky, 40207, United States

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Baton Rouge, Louisiana, 70808, United States

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Hyattsville, Maryland, 20782, United States

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Salisbury, Maryland, 21804, United States

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Silver Spring, Maryland, 20910, United States

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Takoma Park, Maryland, 20912, United States

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Lansing, Michigan, 48912, United States

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Marquette, Michigan, 49855, United States

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Ypsilanti, Michigan, 48197, United States

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Minneapolis, Minnesota, 55407, United States

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Robbinsdale, Minnesota, 55422, United States

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Rochester, Minnesota, 554905, United States

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Hattiesburg Clinic

Hattiesburg, Mississippi, United States

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Columbia, Missouri, 65201, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63110, United States

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Las Vegas, Nevada, 89169, United States

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Lebanon, New Hampshire, 03766, United States

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Morristown, New Jersey, 07960, United States

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Albuquerque, New Mexico, 87106, United States

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Huntington, New York, 11743, United States

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New York, New York, 10032, United States

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Poughkeepsie, New York, 12601, United States

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Utica, New York, 13501, United States

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Charlotte, North Carolina, 28203, United States

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Durham, North Carolina, 27705, United States

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Raleigh, North Carolina, 27610, United States

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Akron, Ohio, 44304, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44195, United States

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Toledo, Ohio, 43608, United States

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Portland, Oregon, 97220, United States

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Allentown, Pennsylvania, 18103, United States

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St Luke's University Health Network

Bethlehem, Pennsylvania, United States

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Danville, Pennsylvania, 17822, United States

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Erie, Pennsylvania, 16550, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Wilkes-Barre, Pennsylvania, 18711, United States

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Germantown, Tennessee, 38138, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75226, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77030, United States

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Plano, Texas, 75093, United States

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The Woodlands, Texas, 77384, United States

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Burlington, Vermont, 05401, United States

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Falls Church, Virginia, 22042, United States

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Leesburg, Virginia, 20176, United States

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Spokane, Washington, 99204, United States

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Madison, Wisconsin, 53715, United States

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Milwaukee, Wisconsin, 53215, United States

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Leuven, Belgium

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Calgary, Alberta, Canada

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London, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Calgary, Canada

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Ottawa, Canada

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La Rochelle, France

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Nantes, France

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Essen, Germany

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Hanover, Germany

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Ulm, Germany

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Eindhoven, Netherlands

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Maastricht, Netherlands

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Nieuwegein, Netherlands

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Rotterdam, Netherlands

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Zurich, Switzerland

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Liverpool, United Kingdom

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Middlesbrough, United Kingdom

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: November 19, 2014
• Study Start: August 1, 2014
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

FR (2); DE (3); CH (1); NL (4); US (81); BE (1); CA (6); GB (2)