The Product Surveillance Registry REVERSE Post Approval Study (PSR-REVERSE)

April 15, 2022 updated by: Medtronic

The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • Ontario
      • London, Ontario, Canada
      • Ottawa, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Quebec City, Quebec, Canada
  • France
      • La Rochelle, France
      • Nantes, France
  • Germany
      • Essen, Germany
      • Hannover, Germany
      • Homburg, Germany
      • Ulm, Germany
  • Italy
      • Reggio Emilia, Italy
  • Netherlands
      • Eindhoven, Netherlands
      • Maastricht, Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands
  • Sweden
      • Skovde, Sweden
  • Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Liverpool, United Kingdom
      • Middlesborough, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Chandler, Arizona, United States, 85226
      • Gilbert, Arizona, United States, 85295
    • Arkansas
      • Jonesboro, Arkansas, United States, 72410
      • Little Rock, Arkansas, United States, 72205
    • California
      • Bakersfield, California, United States, 93301
      • Chula Vista, California, United States, 91910
      • Los Angeles, California, United States, 90048
      • Rancho Mirage, California, United States, 92270
      • Redwood City, California, United States, 94062
      • Salinas, California, United States, 93901
      • San Diego, California, United States, 92103
      • Stanford, California, United States, 94305
      • Torrance, California, United States, 90503
      • Van Nuys, California, United States, 91405
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
      • Lakewood, Colorado, United States, 80228
    • Connecticut
      • New Haven, Connecticut, United States, 06519
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Bradenton, Florida, United States, 34205
      • Clearwater, Florida, United States, 33756
      • Jacksonville, Florida, United States, 32216
      • Safety Harbor, Florida, United States, 34695
    • Georgia
      • Albany, Georgia, United States, 31701
      • Atlanta, Georgia, United States, 30308
      • Marietta, Georgia, United States, 30060
    • Indiana
      • Evansville, Indiana, United States, 47710
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
      • Lexington, Kentucky, United States, 40503
      • Louisville, Kentucky, United States, 40207
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
    • Maryland
      • Hyattsville, Maryland, United States, 20782
      • Salisbury, Maryland, United States, 21804
      • Silver Spring, Maryland, United States, 20910
      • Takoma Park, Maryland, United States, 20912
    • Michigan
      • Lansing, Michigan, United States, 48912
      • Marquette, Michigan, United States, 49855
      • Ypsilanti, Michigan, United States, 48197
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
      • Minneapolis, Minnesota, United States, 55407
      • Robbinsdale, Minnesota, United States, 55422
      • Rochester, Minnesota, United States, 55905
      • Saint Cloud, Minnesota, United States, 56303
      • Saint Paul, Minnesota, United States, 55102
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic
    • Missouri
      • Columbia, Missouri, United States, 65201
      • Kansas City, Missouri, United States, 64111
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New Jersey
      • Morristown, New Jersey, United States, 07960
      • Ocean City, New Jersey, United States, 07712
      • Ridgewood, New Jersey, United States, 07450
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Bay Shore, New York, United States, 11706
      • Bronx, New York, United States
      • Huntington, New York, United States, 11743
      • Manhasset, New York, United States, 11030
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10075
      • Poughkeepsie, New York, United States, 12601
      • Staten Island, New York, United States, 10305
      • Utica, New York, United States, 13501
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
      • Durham, North Carolina, United States, 27705
      • Raleigh, North Carolina, United States, 27610
    • Ohio
      • Akron, Ohio, United States, 44304
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43210
      • Toledo, Ohio, United States, 43608
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
    • Oregon
      • Portland, Oregon, United States, 97220
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Bethlehem, Pennsylvania, United States, 18017
      • Danville, Pennsylvania, United States, 17822
      • Erie, Pennsylvania, United States, 16550
      • Lancaster, Pennsylvania, United States, 17604
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
      • Wilkes-Barre, Pennsylvania, United States, 18711
      • Wynnewood, Pennsylvania, United States, 19096
    • South Carolina
      • Columbia, South Carolina, United States, 29204
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37212
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75226
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78229
      • The Woodlands, Texas, United States, 77384
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Falls Church, Virginia, United States, 22042
      • Leesburg, Virginia, United States, 20176
    • Washington
      • Olympia, Washington, United States, 98506
      • Spokane, Washington, United States, 99204
      • Tacoma, Washington, United States, 98402
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients that are implanted with a Medtronic CRT-D device and meet the expanded indication criteria.

Description

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 with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival from Heart Failure Hospitalization and All-Cause Mortality
Time Frame: 3 years
To estimate the 3-year survival probability of freedom from heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms.
3 years
Survival from Heart Failure Event and All-Cause Mortality
Time Frame: 3 years
To estimate the 3-year survival probability of freedom from heart failure event or all- cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration ≤ 150ms.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSR-REVERSE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe