Heart FailurePSR-REVERSENCT01660035
The Product Surveillance Registry REVERSE Post Approval Study
An observational study of Heart Failure, run by Medtronic at 123 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 155 participants
- Where
- 123 sitesin 10 countries
- Study dates
- Apr 2012to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Heart failure patients that are implanted with a Medtronic CRT-D device and meet the expanded indication criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
123 sites in 10 countries.
123 sites in 10 countries
United States102 sites
Study site
Akron, Ohio, 44304
Study site
Albany, Georgia, 31701
Study site
Albuquerque, New Mexico, 87106
Study site
Allentown, Pennsylvania, 18103
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Anchorage, Alaska, 99508
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Atlanta, Georgia, 30308
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Austin, Texas, 78705
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Bakersfield, California, 93301
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Baton Rouge, Louisiana, 70808
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Bay Shore, New York, 11706
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Bethlehem, Pennsylvania, 18017
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Birmingham, Alabama, 35294
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Bradenton, Florida, 34205
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Burlington, Vermont, 05401
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Chandler, Arizona, 85226
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Charlotte, North Carolina, 28203
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Charlottesville, Virginia, 22908
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Chula Vista, California, 91910
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Cincinnati, Ohio, 45219
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44195
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Colorado Springs, Colorado, 80907
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Columbia, Missouri, 65201
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Columbia, South Carolina, 29204
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Columbus, Ohio, 43210
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Coon Rapids, Minnesota, 55433
Study site
Dallas, Texas, 75226
Study site
Danville, Pennsylvania, 17822
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Durham, North Carolina, 27705
Study site
Edgewood, Kentucky, 41017
Study site
Erie, Pennsylvania, 16550
Study site
Evansville, Indiana, 47710
Study site
Falls Church, Virginia, 22042
Study site
Fort Worth, Texas, 76104
Study site
Germantown, Tennessee, 38138
Study site
Gilbert, Arizona, 85295
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Study site
Houston, Texas, 77030
Study site
Huntington, New York, 11743
Study site
Hyattsville, Maryland, 20782
Study site
Jacksonville, Florida, 32216
Study site
Jonesboro, Arkansas, 72410
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Kansas City, Kansas, 66160
Study site
Kansas City, Missouri, 64111
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Lakewood, Colorado, 80228
Study site
Lancaster, Pennsylvania, 17604
Study site
Lansing, Michigan, 48912
Study site
Lebanon, New Hampshire, 03766
Study site
Leesburg, Virginia, 20176
Study site
Lexington, Kentucky, 40503
Study site
Little Rock, Arkansas, 72205
Study site
Los Angeles, California, 90048
Study site
Louisville, Kentucky, 40207
Study site
Madison, Wisconsin, 53715
Study site
Manhasset, New York, 11030
Study site
Marietta, Georgia, 30060
Study site
Marquette, Michigan, 49855
Study site
Milwaukee, Wisconsin, 53215
Study site
Minneapolis, Minnesota, 55407
Study site
Morristown, New Jersey, 07960
Study site
Nashville, Tennessee, 37212
Study site
New Haven, Connecticut, 06519
Study site
New Hyde Park, New York, 11040
Study site
New York, New York, 10075
Study site
Ocean City, New Jersey, 07712
Study site
Oklahoma City, Oklahoma, 73120
Study site
Olympia, Washington, 98506
Study site
Philadelphia, Pennsylvania, 19104
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Plano, Texas, 75093
Study site
Portland, Oregon, 97220
Study site
Poughkeepsie, New York, 12601
Study site
Raleigh, North Carolina, 27610
Study site
Rancho Mirage, California, 92270
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Redwood City, California, 94062
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Ridgewood, New Jersey, 07450
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Robbinsdale, Minnesota, 55422
Study site
Rochester, Minnesota, 55905
Study site
Safety Harbor, Florida, 34695
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Saint Cloud, Minnesota, 56303
Study site
Saint Paul, Minnesota, 55102
Study site
Salinas, California, 93901
Study site
Salisbury, Maryland, 21804
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92103
Study site
Silver Spring, Maryland, 20910
Study site
Spokane, Washington, 99204
Study site
Stanford, California, 94305
Study site
Staten Island, New York, 10305
Study site
Tacoma, Washington, 98402
Study site
Takoma Park, Maryland, 20912
Study site
The Bronx, New York
Study site
The Woodlands, Texas, 77384
Study site
Toledo, Ohio, 43608
Study site
Torrance, California, 90503
Study site
Utica, New York, 13501
Study site
Van Nuys, California, 91405
Study site
Washington D.C., District of Columbia, 20010
Study site
West Des Moines, Iowa, 50266
Study site
Wilkes-Barre, Pennsylvania, 18711
Study site
Wynnewood, Pennsylvania, 19096
Study site
Ypsilanti, Michigan, 48197
Canada5 sites
Study site
Calgary, Alberta, T2N 4N1
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Québec, Quebec
Germany4 sites
Study site
Essen
Study site
Hanover
Study site
Homburg
Study site
Ulm
Netherlands4 sites
Study site
Eindhoven
Study site
Maastricht
Study site
Nieuwegein
Study site
Rotterdam
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival from Heart Failure Hospitalization and All-Cause Mortality
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.
Measured: 3 years
Survival from Heart Failure Event and All-Cause Mortality
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660035
- Sponsor's protocol ID
- PSR-REVERSE
- Acronym
- PSR-REVERSE
- Status last verified
- Apr 2022
- First submitted
- 6 Aug 2012
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study
- ClinicalTrials.gov ID
- NCT01660035
- Acronym / sponsor ID
- PSR-REVERSE / PSR-REVERSE
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Apr 2012 (actual)
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Heart failure patients that are implanted with a Medtronic CRT-D device and meet the expanded indication criteria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
123 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic at 123 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 123 sites in United States, Canada, Germany, Netherlands, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival from Heart Failure Hospitalization and All-Cause Mortality (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.