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NCT00132977 · ClinicalTrials.gov registry record · Phase 3
RethinQ Study - Evaluating Pacing in Heart Failure Patients
A Phase 3 study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
NCT00132977 is a Phase 3 study that has completed, run by Abbott Medical Devices. The registered enrollment target is 250 participants.
The verdict
NCT00132977, a Phase 3 study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Cardiac Resynchronization Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00132977
The ClinicalTrials.gov registry entry for NCT00132977 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cardiac Resynchronization Therapy is the first listed.
NCT00132977 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00132977 about?
NCT00132977 is a clinical study titled "RethinQ Study - Evaluating Pacing in Heart Failure Patients". 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 si...
What is the current status of trial NCT00132977?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2005-07. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00132977?
The interventions under investigation include: Cardiac Resynchronization Therapy (DEVICE).
Who is sponsoring clinical trial NCT00132977?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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