Edwards CLASP TR EFS

Trial ID or NCT#

NCT03745313

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Christiane Haeffele
Christiane Haeffele
Cardiologist, Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology

View on ClinicalTrials.gov