©2024 Stanford Medicine
TRISCEND II Pivotal Trial
Not Recruiting
Trial ID: NCT04482062
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
Stanford Investigator(s)
Rahul P Sharma, MBBS, FRACP
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Christiane Haeffele
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Eligibility
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
Intervention(s):
device: Edwards EVOQUE System
drug: Optimal Medical Therapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305