Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Trial ID or NCT#
Status
RECRUITING
Purpose
The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.
Official Title
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Eligibility Criteria
- - Undergoing MVS for degenerative MR* with (a) Moderate TR as determined by transthoracic 2D echocardiography, or (b) Tricuspid annular dimension ≥ 40 mm (index: ≥21mm/M2 BSA) and none/trace or mild TR, determined by echocardiography. - Age ≥ 18 years - Able to sign Informed Consent and Release of Medical Information forms - "Degenerative mitral valve disease refers to a spectrum of conditions in which morphologic changes in the connective tissues of the mitral valve cause structural lesions . . ., such as chordal elongation, chordal rupture, leaflet tissue expansion, and annular dilation typically resulting in mitral regurgitation due to leaflet prolapse." This definition excludes rheumatic heart disease. (Anyanwu AC, Adams DH. (2007) Etiological classification of degenerative mitral valve disease: Barlow's disease and fibroelasticity deficiency. Semin Thorac Cardiovasc Surg; 19(2): 90-6).
- - Functional MR - Evidence of sub-optimal fluid management (e.g., lack of diuretics, weight in excess of dry weight) in the opinion of the cardiology investigator - Structural / organic TV disease - Severe TV regurgitation as determined by preoperative transthoracic echocardiography (TTE) - Implanted pacemaker or defibrillator, where the leads cross the TV from the right atrium into the right ventricle - Concomitant cardiac surgery other than atrial fibrillation correction surgery (PVI, Maze, LAA closure), closure of PFO or ASD, or CABG - Cardiogenic shock at the time of randomization - STEMI requiring intervention within 7 days prior to randomization - Evidence of cirrhosis or hepatic synthetic failure - Severe, irreversible pulmonary hypertension in the judgment of the investigator - Pregnancy at the time of randomization - Therapy with an investigational intervention at the time of screening, or plan to enroll patient in additional investigational intervention study during participation in this trial - Any concurrent disease with life expectancy < 2 years - Unable or unwilling to provide informed consent - Unable or unwilling to comply with study follow up in the opinion of the investigator
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Kokil Bakshi
650-498-1232
View on ClinicalTrials.gov
