TRISCEND II Pivotal Trial
Trial ID or NCT#
NCT04482062
Status
NOT RECRUITING
Purpose
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Official Title
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Symptomatic tricuspid regurgitation (TR) despite medical therapy - TR graded as severe or greater - Appropriate for transcatheter tricuspid valve replacement per the local heart team
Exclusion Criteria:
- - Tricuspid valve anatomic contraindications - Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months - Hemodynamic instability - Refractory heart failure requiring advanced intervention - Currently participating in another investigational study
Investigator(s)
Rahul P Sharma, MBBS, FRACP
Cardiologist,
Interventional cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Christiane Haeffele
Cardiologist,
Adult congenital heart disease cardiologist
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Clinical Assistant Professor, Pediatrics - Cardiology
View on ClinicalTrials.gov
