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Biventricular Pacing In Patients With Left Ventricular Dysfunction After Cardiovascular Surgery
NCT00321295 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health East, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00321295 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00321295?
The interventions under investigation include: Atrial synchronous bi-ventricular pacing (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00321295?
This trial is sponsored by Corewell Health East, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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