Comparing 4 approaches for tricuspid regurgitation

Exclusion

• −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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
• −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
• −Any of the following cardiovascular procedures:
• −Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
• −Direct current cardioversion within the last 30 days prior to the point of enrollment
• −Leadless RV pacemaker implant within the last 30 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
• −Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• −Patient is currently participating in another investigational biologic, drug, or device clinical study
• −Patient has other medical, social, or psychological conditions that preclude appropriate consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →, or the patient is under guardianship
• −Any patient considered to be vulnerable
• −Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)
• −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
• −Carotid surgery within 30 days prior to the point of enrollment
• −Cardiac surgery within 90 days prior to the point of enrollment