TRISCEND II Pivotal Trial

Inclusion Criteria:

• Age ≥ 18 years old

• Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR,symptoms from TR, or prior heart failure hospitalization from TR. Patient must be onOMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has adocumented history of intolerance.

• Functional and/or degenerative TR graded as at least severe on a transthoracicechocardiogram (assessed by the echo core lab using a 5-grade classification)

• The Local Heart Team determines that the patient is appropriate for transcathetertricuspid valve replacement

• Patient is willing and able to comply with all study evaluations and provideswritten informed consent.

Exclusion Criteria:

• Anatomy precluding proper device delivery, deployment and/or function

• LVEF < 25%

• Evidence of severe right ventricular dysfunction

• Any of the following pulmonary pressure parameters:

1. PASP >60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)

2. PASP >70 mmHg by RHC

3. PVR >5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP >85 mmHgafter vasodilator challenge)

• Previous tricuspid surgery or intervention

• Presence of trans-tricuspid pacemaker or defibrillator lead with any of thefollowing:

1. Implanted in the RV within the last90 days

2. Patient is pacemaker dependent5 on trans-tricuspid lead without alternativepacing option

3. Has delivered appropriate ICD therapy

• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.

• Active endocarditis within the last 90 days or infection requiring antibiotictherapy (oral or intravenous) within the last 14 days

• Hemodynamically significant pericardial effusion

• Significant intra-cardiac mass, thrombus, or vegetation.

• Clinically significant, untreated coronary artery disease requiringrevascularization, evidence of acute coronary syndrome, recent myocardial infarctionwithin the last 30 days.

• Any of the following cardiovascular procedures:

1. Percutaneous coronary, intracardiac, or endovascular intervention within thelast 30 days

2. Carotid surgery within the last 30 days

3. Direct current cardioversion within the last 30 days

4. Leadless RV pacemaker implant within the last 30 days

5. Cardiac surgery within the last 90 days

• Known history of untreated severe symptomatic carotid stenosis (>50% by ultrasound)or asymptomatic carotid stenosis (>70% by ultrasound)

• Need for emergent or urgent surgery for any reason, any planned cardiac surgerywithin the next 12 months (365days), or any planned percutaneous cardiac procedurewithin the next 90 days

• Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support orhemodynamic support within the last 30 days

• Patient with refractory heart failure requiring or which required advancedintervention (i.e. left ventricular assist device, transplantation) (ACC/AHA/ESC/EACTS Stage D heart failure)

• Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months (180days)

• Stroke within the last 90 days

• Modified Rankin Scale ≥ 4 disability

• Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25mL/min/1.73m2 or requiring chronic renal replacement therapy.

• Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C

• Patient is oxygen-dependent or requires continuous home oxygen

• Chronic anemia with transfusion dependency or Hgb < 9 g/dL not corrected bytransfusion

• Unable to walk at least 100 meters in a 6-minute walk test

• Thrombocytopenia (Platelet count < 75,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)

• Known bleeding or clotting disorders or patient refuses blood transfusion

• Active gastrointestinal (GI) bleeding within the last 90 days

• Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days).

• Patients in whom (any of the following):

1. TEE is contraindicated or cannot be completed

2. tricuspid valve anatomy is not evaluable by TTE or TEE

• In the opinion of the investigator, access to and through the femoral vein/IVC witha guide sheath and delivery catheter is deemed not feasible (e.g. occluded femoralveins, occluded or thrombosed IVC filter)

• Untreatable hypersensitivity or contraindication to any of the following: allantiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovinetissue, glutaraldehyde, or contrast media

• Currently participating in another investigational biologic, drug or device study

• Co-morbid condition(s) that, in the opinion of the Investigator, limit lifeexpectancy to < 12 months (365 days).

• Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid,amyloidosis, sarcoidosis, hemochromatosis) or significant uncorrected congenitalheart disease (including but not limited to hemodynamically significant atrialseptal defect, RV dysplasia, and arrhythmogenic RV)

• Any condition, in the opinion of the investigator, making it unlikely the patientwill be able to complete all protocol procedures and follow-ups

• Other medical, social, or psychological conditions that preclude appropriate consentand follow-up, including patients under guardianship

• Any patient considered to be vulnerable