Die SPACER-Studie – Korrektur der Trikuspidalklappeninsuffizienz (einer Erkrankung, bei der die Trikuspidalklappe undicht ist und somit das Blut während des Herzzyklus kurzzeitig in der falschen Richtung durch die Trikuspidalklappe strömt) mittels des Edwards FORMA Transkatheter-Trikuspidalklappen-Reparatursystems.

Device: EW Tricuspid Transcatheter Repair System

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