RethinQ Study - Evaluating Pacing in Heart Failure Patients (RethinQ)
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|ClinicalTrials.gov Identifier: NCT00132977|
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : February 4, 2019
Patients with heart failure have a pumping action of the ventricles in which one ventricle contracts before the other ventricle. This uncoordinated (unsynchronized) pumping is due to a delay in the stimulation of the left ventricle because of its increased size. Pacing both the right and the left side of the heart (or cardiac resynchronization therapy [CRT]) has been proven to be effective in the treatment of heart failure (HF). Current market-approved devices combine both pacing (CRT) and shocking (implantable cardioverter defibrillator [ICD]) therapy for patients who have severe heart failure and are at risk for developing life-threatening heart rhythms. These devices provide an electrical pacing stimulus to both ventricles and may help the heart contract in a more coordinated way and improve heart failure symptoms.
The investigational portion of this trial involves the implantation of a market-approved CRT implantable cardioverter defibrillator (CRT-D) system in patients who do not meet the current criteria for a CRT implant. In order to receive a CRT-D implant today, patients must have heart failure symptoms, have a weakened heart muscle, and have uncoordinated pumping of the heart. To demonstrate this uncoordinated pumping of the heart, a test (electrocardiogram [ECG]) is done. It is believed that by using a different test (echocardiogram) to measure whether this uncoordinated pumping is present, more patients will be identified that will benefit from CRT-D therapy. This study will look at whether patients identified by using this echocardiogram test show a benefit from having this CRT-D therapy.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Cardiac Resynchronization Therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Resynchronization Therapy in Normal QRS (RethinQ) Clinical Investigation|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- Cardiac resynchronization therapy (CRT) effectiveness will be evaluated in terms of exercise capacity (peak VO2), as measured by cardiopulmonary exercise testing [ Time Frame: 6 months ]
- Safety will be evaluated in terms of survival from CRT-D system-related complications. [ Time Frame: 6 months ]
- Quality of Life Questionnaire [ Time Frame: 6 months ]
- New York Heart Association (NYHA) Classification [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132977
|Study Chair:||John Beshai, MD||University of Chicago|