Eighteen (18) years of age or older

Patient is deemed symptomatic despite medical therapy and confirmed by the local Heart Team

Severe or greater tricuspid regurgitation

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

Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team

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

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. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)

Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:

Would prevent proper TR reduction due to interaction of the lead with the leaflets

Were implanted in the RV within the last 90 days prior to the point of enrollment

Primary non-degenerative tricuspid disease

Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL

Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial 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 arrhythmogenic RV
Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days

Any of the following cardiovascular procedures:
1. Percutaneous coronary, intracardiac, or endovascular intervention within the
  last 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 of
  enrollment
4. Leadless RV pacemaker implant within the last 30 days prior to the point of
  enrollment
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 asymptomatic carotid stenosis

Active endocarditis within the last 90 days or infection requiring antibiotic therapy 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 the judgment of the Investigator

Patient is currently participating in another investigational biologic, drug, or device clinical study
Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship

Any patient considered to be vulnerable

• 2019-07

• Cardiovascular Diseases

• CLASP II TR

• Heart Diseases

• Heart Valve Diseases

• Tricuspid Valve Insufficiency

• Cardiology

• Edwards Lifesciences