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Edwards CLASP TR EFS
Recruiting
Trial ID: NCT03745313
Purpose
Early feasibility study to assess the safety and performance of the Edwards PASCAL
Transcatheter Valve Repair System in tricuspid regurgitation
Official Title
Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
Stanford Investigator(s)
Christiane Haeffele
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Eligibility
Inclusion Criteria:
- Severe functional or degenerative TR
- Symptomatic despite medical therapy
- The local site Heart Team determines that the patient is appropriate for transcatheter
tricuspid valve repair
Exclusion Criteria:
- Unsuitable anatomy
- Previous tricuspid valve repair or replacement
- Co-morbid condition(s) that, in the opinion of the investigator, could limit the
patient's ability to participate in the study, including compliance with follow-up
requirements, or that could impact the scientific integrity of the study
Intervention(s):
device: Edwards PASCAL Transcatheter Valve Repair System
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305