CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 684 enrolled
Drug / intervention
Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRTdevice
Likely dose
Medtronic CRT or CRT/ICD device implantation (market-released)AI-extracted
Key inclusion· 4
  • ✓NYHA Class I (asymptomatic) or NYHA Class II (mild symptoms)
  • ✓QRS interval ≥120 ms
  • ✓Left ventricular ejection fraction (LVEF) ≤40%
  • ✓Left ventricular end diastolic dimension (LVEDD) ≥55 mm
Key exclusion· 3
  • ✕Pacemaker dependent
  • ✕NYHA Class III or IV heart failure
  • ✕Hospitalized for heart failure within past 3 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00271154
NCT00271154N/ACompleted
CompareCT.gov

REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Dec 30, 2005·Updated Jan 30, 2012

In Brief

A clinical study evaluating Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT for Heart Failure. Completed, enrolled 684 participants across 65 sites in 15 countries.

Detailed Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. The purpose of the REVERSE clinical trial is to determine whether pacing in both the left and right ventricles using Cardiac Resynchronization Therapy (CRT) can help slow the progression of heart failure in people who have mild or previous symptoms and poor heart pumping function. This kind of therapy has previously been shown to reduce symptoms and improve exercise capacity in people with more advanced forms of heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesAustria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Ireland, Italy, Norway, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 30, 2005
Enrollment StartSep 1, 2004
Primary CompletionOct 1, 2007
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.5 years ago

Interventions

Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRTdevice

All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.