Status:
COMPLETED
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Cardiac Surgery
Tricuspid Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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 sympto...
Detailed Description
Study Design: This is a single-center prospective, randomized controlled clinical trial. Enroll/Randomize: mitral operation alone, or mitral operation with tricuspid valve repair. Randomization will...
Eligibility Criteria
Inclusion
- All patients 18-65 + older years undergoing mitral valve surgery.
- Presence of moderate or mild-moderate tricuspid regurgitation as read on any echocardiographic study performed within 6 months prior to operation. Assessment if tricuspid regurgitation will be performed using an integrative method.
- All patients referred for mitral valve surgery.
- Able to understand the consent and able to sign informal consent.
Exclusion
- Patients under 18 years of age.
- Patient with structural/ organic tricuspid valve disease.
- Refusal/ Inability to sign informal consent form.
- Pregnant women.
- Tricuspid valve endocarditis.
- Requirement for concomitant cardiac surgery (other than atrial fibrillation correction surgery, closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or coronary artery bypass surgery).
- Cardiogenic shock at the time of randomization.
- ST segment elevation myocardial infarction requiring Intervention within 7 days prior to randomization.
- Evidence of cirrhosis or hepatic synthetic failure.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01246947
Start Date
September 1 2010
End Date
February 1 2017
Last Update
May 8 2023
Active Locations (1)
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1
University of Maryland, School of Medicine
Baltimore, Maryland, United States, 21201