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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
684
All randomized patients will be implanted with a market-released Medtronic CRT or CRT/ICD device.
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Huntsville, Alabama, United States
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Anchorage, Alaska, United States
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Redwood City, California, United States
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San Diego, California, United States
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Atlantis, Florida, United States
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Percentage of Patients Worsened for Clinical Composite Response
Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.
Time frame: 12 Months
Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)
The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.
Time frame: Baseline to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jacksonville, Florida, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Boston, Massachusetts, United States
...and 55 more locations