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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation.
This study is evaluating the PASCAL device, a minimally invasive treatment for severe tricuspid valve leakage (tricuspid regurgitation), in patients who qualify for the procedure. The goal is to provide continued access to this treatment and assess its safety and effectiveness by monitoring participants? health, hospitalizations, survival, and quality of life over time. Participants will be followed for at least 24 months, with long-term follow-up extending up to 5 years.
Sahar Razmjou - srazmjo1@hfhs.org
• Age 18 or older
• Severe or greater tricuspid regurgitation
• New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization within 12 months
• Intermediate or greater surgical risk as determined by Heart Team
• Patient agrees to provide informed consent, follow protocol procedures, and will comply with follow-up visit requirements
• Tricuspid valve anatomy not suitable for device including previous repair or replacement that may interfere with the device
• Significant heart mass, clot, or vegetation
• Severe right ventricle (RV) dysfunction
• Other tricuspid valve disease
• Presence of trans-tricuspid pacemaker or defibrillator leads deemed unsuitable
• Severe existing aortic, mitral, or pulmonic valve disease
Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement - ENVISION
This study evaluates the safety and effectiveness of the Navitor TAVI system in patients with severe aortic valve narrowing who are at low or moderate surgical risk, aiming to expand its approval. It also includes patients needing valve-in-valve procedures(high surgical risk) for failing artificial valves and those with bicuspid aortic valves to better understand outcomes in these groups.
Sureja Sundaralingam - ssundar4@hfhs.org
• Moderate to severe symptoms from their heart condition that affect daily activities
• Severe narrowing of the aortic valve caused by age-related wear and tear
• Bicuspid Valve Cohort - Aortic valve with two flaps instead of three
• Valve-in-Valve Cohort - high or greater risk for open-heart surgery