The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.

Inclusion Criteria:

1. Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
2. Eighteen years of age or older
3. Clinically significant, symptomatic (New York Heart Association (NYHA) Functional Class II or greater), tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team
4. Functional tricuspid regurgitation as the primary etiology
5. New York Heart Association (NYHA) Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
6. Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device
7. Willing to attend study follow-up assessments for up to 3 years

Exclusion Criteria

1. Tricuspid valve/right heart anatomy not suitable for the study device:

   1. Native tricuspid annulus area < 2.14 cm2 (9 mm device) or < 2.63 cm2 (12 mm device) or < 3.27cm2 (15 mm device) as measured by transthoracic echocardiography
   2. Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval
   3. Access pathway vessel diameter less than 7.1 mm (9, 12 mm and 15 mm devices)

2. Moderate or greater tricuspid valve stenosis

3. Untreated clinically significant coronary artery disease requiring immediate revascularization

4. Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure

5. Patients not already receiving dialysis with renal insufficiency (eGFR <25) per lab test ≤ 48 hours prior to scheduled implant procedure

6. Myocardial infarction within 30 days of scheduled implant procedure

7. Hemodynamic instability within 30 days of scheduled implant procedure

8. Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure

9. Severe left ventricular dysfunction with ejection fraction < 25% within 90 days of scheduled implant procedure

10. Patients with pulmonary artery systolic pressure > 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days

11. Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement

12. Active endocarditis or infection within 3 months of scheduled implant procedure

13. Cerebrovascular accident within 3 months of scheduled implant procedure

14. Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation

15. Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure

16. Evidence of right sided intracardiac mass, thrombus, or vegetation

17. Prior venous stent placed within the access route (e.g., sub-clavian vein) that could negatively react with device

18. Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve

19. Known hypersensitivity to cobalt chromium, nitinol or titanium

20. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated

21. Patient is a current intravenous drug user

22. Female of child-bearing potential is pregnant or lactating

23. Patient is currently participating or has participated in another investigational drug or device clinical study within 30 days of study screening activity

24. Patient requires emergent/emergency treatment for tricuspid insufficiency

25. Patient is under guardianship