Personalized CRT - PSR

NCT03723265 | Completed

• 1 other identifier: Personalized CRT
• Study Type: observational
• Target: 1,517
• Locations: 12 countries
• Sites: 121

Brief Summary

The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• CRT Response

  A Clinical Composite Score (CCS) endpoint will be used to assess a change in CRT response for all patients from baseline to follow-up visits.

  Every 3-9 months

Secondary Outcomes (3)

• Treatments for CRT non-response

  Every 3-9 months

• Treatment effects for different CRT features in the CRT non-responder population

  Every 3-9 months

• Patient outcome post initial CRT implant

  Every 3-9 months

Interventions

Cardiac Resynchronization Therapy DEVICE

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients that are or will be implanted with an eligible CRT system.

You may 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 or be treated with an eligible CRT device
• Patient within 30 days of therapy received at the time of their initial PSR platform enrollment

You may not qualify if:

• 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 (122)

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Birmingham, Alabama, United States

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Anchorage, Alaska, United States

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Gilbert, 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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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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Denver, Colorado, United States

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Lakewood, Colorado, 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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Jacksonville, Florida, United States

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Safety Harbor, Florida, United States

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Albany, 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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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Clinton, 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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Worcester, 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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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 Louis Park, Minnesota, 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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Las Vegas, Nevada, United States

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Morristown, New Jersey, United States

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Ocean Township, New Jersey, United States

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Albuquerque, New Mexico, United States

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Garden City, New York, 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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Toledo, Ohio, 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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Kingsport, 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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Plano, Texas, United States

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The Woodlands, Texas, United States

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Burlington, Vermont, 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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Leuven, 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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Clermont-Ferrand, France

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La Rochelle, France

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Montpellier, France

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Nantes, France

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Pringy, France

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Aachen, Germany

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Cologne, Germany

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Essen, Germany

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Hanover, Germany

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Homburg, Germany

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Tübingen, Germany

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Ulm, Germany

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Milan, Italy

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Reggio Emilia, Italy

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Kuala Lumpur, Malaysia

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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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Belgrade, Serbia

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Seoul, South Korea

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A Coruña, Spain

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Palma de Mallorca, Spain

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Skövde, Sweden

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Birmingham, United Kingdom

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Liverpool, United Kingdom

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Manchester, United Kingdom

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Middlesbrough, United Kingdom

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MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 29, 2018
• Study Start: January 1, 2012
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

US (88); IT (2); GB (4); DE (7); FR (5); MY (1); SE (1); NL (4); BE (2); CA (4); KR (1); ES (2)