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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.

Status: Recruiting

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.

I'm interested

Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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
Exclusion Criteria:

• 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
Interventions:

Drug/Device: Pascal

Conditions:

Patient with severe tricuspid regurgitation

Keywords:

TEER, trans catheter edge to edge repair, Tricuspid Regurgitation

Contact(s): Sahar Razmjou - srazmjo1@hfhs.org
Principal Investigator: Brian O'Neill
Principal Investigator ID: boneil3@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov

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