Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Inclusion Criteria:

• Eighteen (18) years of age or older

• Despite medical therapy, per the local Heart Team, patient has signs of TR, symptomsfrom TR, or prior heart failure hospitalization from TR.

• Severe or greater tricuspid regurgitation

• New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization inthe prior 12 months

• Patient is at an intermediate or greater estimated risk of mortality with tricuspidvalve surgery as determined by the cardiac surgeon with concurrence by the localHeart Team

• Patient is able and willing to give informed consent, follow protocol procedures,and comply with follow-up visit requirements

Exclusion Criteria:

• Tricuspid valve anatomy not evaluable by TTE or TEE

• Tricuspid valve anatomy precludes proper device deployment and function

• Patient with refractory heart failure requiring, advanced intervention (i.e. patienthas or will need left ventricular assist device, or transplantation) (ACC/AHA StageD heart failure)

• Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of thefollowing:

1. Would prevent proper TR reduction due to interaction of the lead with theleaflets

2. Were implanted in the RV within the last 90 days prior to the point ofenrollment

• Primary non-degenerative tricuspid disease

• Previous tricuspid valve repair or replacement that would interfere with placementof PASCAL

• Clinically significant, untreated coronary artery disease requiringrevascularization, unstable angina, evidence of acute coronary syndrome, recentmyocardial infarction

• Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment

• Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days

• Recent Stroke

• Active gastrointestinal (GI) bleeding

• Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid,amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease,including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenicRV

• Need for emergent or urgent surgery for any reason, any planned cardiac surgerywithin the next 12 months (365 days), or any planned percutaneous cardiac procedurewithin the next 90 days

• Any of the following cardiovascular procedures:

1. Percutaneous coronary, intracardiac, or endovascular intervention within thelast 30 days prior to the point of enrollment

2. Carotid surgery within 30 days prior to the point of enrollment

3. Direct current cardioversion within the last 30 days prior to the point ofenrollment

4. Leadless RV pacemaker implant within the last 30 days prior to the point ofenrollment

5. Cardiac surgery within 90 days prior to the point of enrollment

• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation

• Known history of untreated severe symptomatic carotid stenosis or asymptomaticcarotid stenosis

• Active endocarditis within the last 90 days or infection requiring antibiotictherapy within the last 14 days

• Patient is oxygen-dependent or requires continuous home oxygen

• Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)

• Concurrent medical condition with a life expectancy of less than 12 months in thejudgment of the Investigator

• Patient is currently participating in another investigational biologic, drug, ordevice clinical study

• Patient has other medical, social, or psychological conditions that precludeappropriate consent and follow-up, or the patient is under guardianship

• Any patient considered to be vulnerable