Patients must be at least 21 years old.
The patient must have severe, symptomatic (ACC/AHA Stage D symptoms) tricuspid regurgitation (TR) as assessed by 2D echocardiogram with evidence of peripheral and central venous congestion (specifically lower extremity edema and abdominal ascites requiring diuretics.)
The patient must be evaluated by a "heart team" of physicians including an interventional cardiologist, cardiothoracic surgeon, heart failure specialist, and imaging specialist, and presented for review at a local multi-disciplinary conference. By consensus, the heart team must agree (and verify in the case review process) that valve implantation will likely benefit the patient.
The heart team must agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Also, other factors which may increase the patients perceived surgical risk for inclusion in the trial will be clearly delineated if they are present. These include, but are not limited to the following as defined by VARC 2: Frailty, Hostile chest, porcelain aorta, IMA or other critical conduit crossing the midline or adherent to the posterior table of sternum, severe right ventricular (RV) dysfunction. The surgeons' consultation notes shall specify the medical or anatomic factors leading to that conclusion. At least one of the cardiac surgeon assessors must have interviewed and examined the patient.
The study patient provides informed consent and agrees to comply with all required post-procedure follow-up visits, including annual visits up to 5 years.

NCT02339974_inc_T1
Person
old
NCT02339974_inc_T2
Value
at least 21 years
NCT02339974_inc_T3
Qualifier
severe
NCT02339974_inc_T4
Qualifier
symptomatic
NCT02339974_inc_T5
Condition
tricuspid regurgitation
NCT02339974_inc_T6
Condition
TR
NCT02339974_inc_T7
Measurement
ACC/AHA
NCT02339974_inc_T8
Value
Stage D
NCT02339974_inc_T9
Procedure
2D echocardiogram
NCT02339974_inc_T10
Condition
eripheral enous congestion
NCT02339974_inc_T11
Condition
central venous congestion
NCT02339974_inc_T12
Condition
lower extremity edema
NCT02339974_inc_T13
Condition
abdominal ascites
NCT02339974_inc_T14
Drug
diuretics
NCT02339974_inc_T15
Scope
peripheral and central venous congestion
NCT02339974_inc_T16
Scope
lower extremity edema and abdominal ascites requiring diuretics