Ignite Creation Date:
2024-05-05 @ 11:04 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01246947
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2010-11-22
Brief Title:
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Prospective Randomized Trial of Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Mitral Operation
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 dont 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
Detailed Description:
Study Design
This is a single-center prospective randomized controlled clinical trial
EnrollRandomize mitral operation alone or mitral operation with tricuspid valve repair Randomization will occur before operation
Operation The surgeon will perform mitral surgery and only those patients randomized to tricuspid valve repair will perform tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques
This is a single-center prospective randomized controlled clinical trial
EnrollRandomize mitral operation alone or mitral operation with tricuspid valve repair Randomization will occur before operation
Operation The surgeon will perform mitral surgery and only those patients randomized to tricuspid valve repair will perform tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None