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NCT01246947 · ClinicalTrials.gov registry record · NA
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
A NA study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT01246947 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 57 participants.
The verdict
NCT01246947, a NA study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study Summary
The mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either fix or replace the valve. Many patients with mitral valve disease also develop a leaky tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart (the right heart pumps blood across the lungs). The amount of leakiness of the tricuspid valve is determined by an ultrasound test, and the amount of leakiness is graded as: none, mild, moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral valve, he or she will fix the tricuspid valve if the tricuspid leakage is severe. This involves sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid valve leakage is only mild (or absent), the surgeon will leave the tricuspid valve alone at the time of mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are uncertain about what to do. In a recent review of thousands of patients across the nation having mitral valve surgery with moderately leaky tricuspid valves, 35 % of patients had tricuspid valve repair. Since the investigators don't know what the best approach is: to leave the moderately leaky tricuspid valve alone or to fix it with a cloth-covered ring, the investigators propose a study to determine which approach is best. Patients having mitral valve surgery with a moderately leaky tricuspid valve will be randomized to either 1. have a tricuspid valve repair or 2. to not have a tricuspid valve repair. The investigators will carefully follow these patients for two years and see if heart function is better among those who got their valve fixed.
Interventions
- PROCEDURE Tricuspid valve repair
- OTHER Mitral surgery alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2010-09 |
| Est. Completion | 2017-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01246947
The ClinicalTrials.gov registry entry for NCT01246947 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tricuspid valve repair is the first listed.
NCT01246947 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01246947 about?
NCT01246947 is a clinical study titled "Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation". The mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either fix or replace the valve. M...
What is the current status of trial NCT01246947?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2010-09. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01246947?
The interventions under investigation include: Tricuspid valve repair (PROCEDURE), Mitral surgery alone (OTHER).
Who is sponsoring clinical trial NCT01246947?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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