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NCT00321295 · ClinicalTrials.gov registry record · Phase 3
Biventricular Pacing In Patients With Left Ventricular Dysfunction After Cardiovascular Surgery
A Phase 3 study of Heart Failure, Congestive and Cardiomyopathy, sponsored by Corewell Health East.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00321295 is a Phase 3 study of Heart Failure, Congestive and Cardiomyopathy that has completed, run by Corewell Health East. The registered enrollment target is 40 participants, below the 641-participant average among 33 other Heart Failure, Congestive trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00321295, a Phase 3 study of Heart Failure, Congestive and Cardiomyopathy, has completed, sponsored by Corewell Health East.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Congestive heart failure (CHF) is a medical condition that is due to left ventricular systolic dysfunction (LVSD). LVSD is a decreased ability of the heart to pump blood forward. There are 5 million people in the United States that have CHF and 52,828 new cases are diagnosed annually. There are 995,000 hospital visits and 52,828 deaths annually due to CHF. Previous studies have shown that people with this condition are at a higher risk for complications immediately after any type of heart surgery than are normal individuals. This includes increased dependence on medications and devices to improve the pumping function of the heart and blood pressure. Additionally, they also have longer lengths of hospital stay and higher rates of death compared to normal individuals. Some patients with LVSD not only have a decreased pumping ability of the heart, they also have an inefficient pumping function. These patients have been shown to benefit from a device therapy known as biventricular pacing. Biventricular pacing involves simultaneously electrically stimulating the two major pumping chambers of the heart known as ventricles using a pacemaker and wires. This causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure. Studies have confirmed that in these patients, implantation of a biventricular pacemaker improves patients' symptoms and quality of life as well as decreasing a need for future hospitalizations. Whether biventricular pacing in patients with LVSD improves patient outcomes after heart surgery has not been investigated. Some patients temporarily develop slow heart rates after cardiovascular surgery. These slow heart rates can cause a decrease in the blood pumped from the heart and result in low blood pressures. Therefore, all patients undergoing cardiovascular surgery, regardless of left ventricular function, receive temporary pacing wires that are placed on one of the ventricles dur
Conditions Studied
Interventions
- DEVICE Atrial synchronous bi-ventricular pacing
Study Locations (1)
Michigan
- William Beaumont Hospital - Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-08 |
| Est. Completion | 2006-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00321295
The ClinicalTrials.gov registry entry for NCT00321295 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 641-participant average among 33 other Heart Failure, Congestive trials with a reported enrollment target (94% lower). The listed sponsor is Corewell Health East, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Heart Failure, Congestive appearing as the primary indexed condition, and to 1 intervention - of which Atrial synchronous bi-ventricular pacing is the first listed.
NCT00321295 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT00321295 about?
NCT00321295 is a clinical study titled "Biventricular Pacing In Patients With Left Ventricular Dysfunction After Cardiovascular Surgery". Congestive heart failure (CHF) is a medical condition that is due to left ventricular systolic dysfunction (LVSD). LVSD is a decreased ability of the heart to pump blood forward. There are 5 million people in the United States that have CHF and 52,828 new cases are diagnosed annually. There are 995,...
What is the current status of trial NCT00321295?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2004-08. Estimated completion is 2006-10.
What conditions does trial NCT00321295 study?
This clinical trial studies the following conditions: Heart Failure, Congestive, Cardiomyopathy, Thoracic Surgery.
What interventions are being tested in trial NCT00321295?
The interventions under investigation include: Atrial synchronous bi-ventricular pacing (DEVICE).
Who is sponsoring clinical trial NCT00321295?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00321295 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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