Clinical Trials

Inclusion Criteria:

* Patient has clinically significant TR graded as severe or greater
* Peak central venous pressure of ≥ 15mmHg
* Patient has NYHA functional classification of III or IV
* Patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care TR therapy and remains symptomatic

Exclusion Criteria:

Patients will be excluded from participation if ANY of the following criteria apply:

* Severe RV dysfunction defined by TAPSE, RVEF, or RVFAC.
* Anatomical suitability according to CT scan.
* Systolic Pulmonary Artery Pressure \> 65mmHg
* Moderate or more mitral valve stenosis
* Greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation
* Moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation
* Kidney dysfunction with estimated Glomerular Filtration Rate (eGFR) \< 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis
* Liver cirrhosis or moderate or severe liver disease (Child-Turcotte-Pugh class B or C, or a score of 7 or higher)
* Thrombocytopenia (Platelet count\< 100,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3) within 14 days of the index procedure
* In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy \< 12 months

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/26/2024. Questions regarding updates should be directed to the study team contact.