Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

Inclusion Criteria:

1. 22 - 90 years of age at the time of the study procedure

2. Symptomatic tricuspid regurgitation despite being adequately treated with optimalmedical therapy by the Local Heart Team for at least 30 days prior to the time ofstudy consent.

3. Severe, massive or torrential tricuspid regurgitation determined by qualifyingtransthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE) usingthe 5-grade classification.

4. Candidate felt suitable for transcatheter tricuspid valve replacement as determinedby the local heart team and confirmed by the patient selection committee. Forpatients with pre-existing trans-tricuspid pacemaker or ICD leads, the local heartteam shall include an electrophysiologist.

5. Subject or legally authorized representative has provided informed consent andagrees to return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Estimated life expectancy of less than 12 months

2. PVR >5 Wood units

3. Echocardiographic evidence of severe right ventricular dysfunction

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

5. Presence of significant congenital heart disease including but not limited tohemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenicRV.

6. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotidsurgery, within last 30 days. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator or leadless pacemakerwithin 90 days prior to the study procedure

7. Stroke or other major cerebrovascular event within 90-days prior to index procedure

8. Untreated clinically significant coronary artery disease requiringrevascularization, recent (within last 30 days) acute coronary syndrome ormyocardial infarction.

9. Bleeding disorders including thrombocytopenia or platelet count <70,000 mm3 orthrombocytosis (platelet count >700,000 /mm3)

10. Current or planned pregnancy within next 12 months for women of childbearingpotential

11. Active or recent endocarditis within last 90 days or, sepsis/ other systemicinfection requiring oral or intravenous antibiotics within last 30 days

12. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements. Any patient considered to be vulnerable.

13. Left ventricular ejection fraction (LVEF) < 30%