The Product Surveillance Registry REVERSE Post Approval Study

NCT ID: NCT01660035

Last Updated: 2022-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2022-04-30

Brief Summary

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The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.

Detailed Description

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The REVERSE PAS will estimate the 3-year survival probability of freedom from heart failure hospitalization and heart failure events in patients implanted with a Medtronic CRT-D device who meet the expanded indication criteria with a QRS duration ≤ 150 ms.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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 a Medtronic CRT-D who meets the expanded CRT-D indication criteria with a QRS ≤ 150ms
* Patient within 30 days of implant

Exclusion Criteria

* Patient who is, or will 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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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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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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Los Angeles, 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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Colorado Springs, 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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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Evansville, 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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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, 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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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 Clinic

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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Lebanon, New Hampshire, United States

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Morristown, 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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Bay Shore, 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 Hyde Park, 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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Staten Island, New York, United States

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The Bronx, New York, United States

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Utica, New York, United States

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Charlotte, North Carolina, 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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Wynnewood, 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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San Antonio, Texas, United States

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The Woodlands, 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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Leesburg, Virginia, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Tacoma, 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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Calgary, Alberta, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, 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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Homburg, , Germany

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Ulm, , Germany

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Reggio Emilia, , Italy

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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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Skövde, , Sweden

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Zurich, , Switzerland

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Liverpool, , United Kingdom

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Middlesbrough, , United Kingdom

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Countries

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United States Belgium Canada France Germany Italy Netherlands Sweden Switzerland United Kingdom

Other Identifiers

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PSR-REVERSE

Identifier Type: -

Identifier Source: org_study_id

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