Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation

Inclusion Criteria:

1. The patient is symptomatic (New York Heart Association Functional Class II, III orambulatory class IV) despite Standard Of Care (SOC). The Central Screening Committee (CSC) will assess whether the patient is receiving SOC. The CSC will also ensure thatin case of the presence of atrial fibrillation, left sided heart valve disease (notrequiring intervention) or coronary artery disease, conditions are first treatedadequately with medication and/or (surgical) intervention.
2. The patient suffers from ≥ grade 3 isolated TR as determined by the assessment of aqualifying transthoracic echocardiogram (TTE) and three-dimensional transesophagealechocardiogram (3DTEE) and confirmed by the CSC, according to European Association forPercutaneous Cardiovascular Interventions (Tricuspid Focus Group) consensus document (in press). Note: If cardiac procedure(s) occur after eligibility was determined, TRgrade will be re-assessed 30 days after the procedure.
3. The cardiac surgeon of the sites' local heart team concurs that the patient is at highestimated risk for mortality or morbidity with TV surgery.
4. The patient is ≥18 years of age at time of consent.
5. The patient must provide written informed consent prior to any trial relatedprocedure.

Exclusion Criteria:

1. Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonaryhypertension as assessed by right heart catheterization. Severe uncontrolledhypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mmHg.
2. Any condition that would interfere with a TTVr procedure, such as prior tricuspidvalve repair or tricuspid valve leaflet anatomy which may preclude device implantation (e.g. calcification in grasping area, a severe coaptation defect of the tricuspidleaflets (no clip placement possible), pacemaker or Implantable CardioverterDefibrillator (ICD) leads that would prevent appropriate placement or visualization ofTTVr devices, Ebstein Anomaly (normal annulus position, but valve leaflets attached towalls and septum of the right ventricle), tricuspid valve anatomy non evaluable byecho, known allergy or hypersensitivity to dual antiplatelet therapy AND anticoagulanttherapy or to device materials, femoral venous mass or thrombus or vegetation.
3. Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation)or pulmonary valve correction within prior 60 days. Note: concomitant mitral valvedisease (e.g. mitral regurgitation) will be treated first and patients will bereassessed for the trial after 60 days.
4. Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/ormean gradient ≥5 mmHg.
5. Left Ventricular Ejection Fraction (LVEF) ≤20%
6. Active endocarditis, active rheumatic heart disease, other ongoing infection requiringantibiotic therapy (enrolment possible 30 days after discontinuation of antibioticswith no active infection) or leaflets degenerated from rheumatic disease (i.e.noncompliant, perforated)
7. Myocardial infarction known unstable angina, or percutaneous coronary interventionwithin prior 30 days.
8. Hemodynamic instability defined as systemic systolic pressure <90 mmHg with or withoutafterload reduction, cardiogenic shock or the need for inotropic support orhemodynamic support device (e.g. intra-aortic balloon pump).
9. Cerebrovascular Accident (CVA) within prior 90 days
10. Chronic dialysis
11. Bleeding disorders or hypercoagulable state, inability to use dual antithrombotictherapy due to contraindication, allergy or hypersensitivity
12. Active peptic ulcer or active gastrointestinal (GI) bleeding
13. Life expectancy of less than 12 months
14. Subject currently participating in another clinical trial (not yet completed primaryendpoint) or in another clinical investigation for valvular heart disease.
15. Pregnant or nursing patients or those who plan pregnancy during the course of thetrial. Women of childbearing age are required to have a negative pregnancy test 7 daysprior to baseline visit. Women of childbearing age should be instructed to use safecontraception or have a sterilized regular partner.
16. Presence of anatomic or comorbid conditions, or other medical, social or psychologicalconditions that, in the eye of the investigator, limits the subject's ability toparticipate in the clinical investigation or comply with follow-up requirements, orimpact the scientific soundness of the investigation results.