Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

The tricuspid valve controls the flow of blood in your heart between the right ventricle and
the right atrium. TR is a condition where the valve does not close fully when it is supposed
to and blood can then leak back into the right atrium. When TR becomes severe, surgery is
usually performed to correct it. The purpose of the research is to determine whether
repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned
mitral valve surgery, would improve the heart health of those who receive it compared to
those who do not. There are no new or "experimental" procedures being tested in this study:
both the mitral valve procedure and the tricuspid valve repair procedure are well established
surgeries and are regularly performed together in patients who have severe TR. The available
evidence addressing this issue is not definite: it is based on less rigorous methods of
investigation, and the results have been conflicting. The study being proposed here will use
rigorous scientific methods and should result in a very high level of certainty about what
surgical treatment is best for patients with your condition.

This study will enroll people scheduled for mitral valve surgery with mild to moderate
tricuspid regurgitation.

Inclusion 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 trace/mild TR, determined by echocardiography.

- Age ≥ 18 years

- Able to sign Informed Consent and Release of Medical Information forms

Exclusion Criteria:

- 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