2019-06 TRISCEND Study
Trial ID or NCT#
NCT04221490
Status
RECRUITING
Purpose
Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System
Official Title
Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Functional or degenerative TR moderate or greater - Symptomatic despite medical therapy or prior HF hospitalization from TR - The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement Key
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 in which the patient has not reached a primary endpoint
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
Jack Boyd
Cardiac surgeon,
Cardiothoracic surgeon,
Heart transplant surgeon,
Heart and lung transplant surgeon,
Vascular surgeon,
Cardiovascular surgeon,
Lung transplant surgeon
Clinical Associate Professor, Cardiothoracic Surgery
Mirela Tuzovic
Cardiologist,
Radiologist
Clinical Assistant Professor, Medicine - Cardiovascular Medicine
John W. MacArthur
Cardiothoracic surgeon,
Cardiac surgeon,
Cardiovascular surgeon,
Lung transplant surgeon
Assistant Professor of Cardiothoracic Surgery (Adult Cardiac Surgery)
David Lee, MD
Cardiologist,
Interventional cardiologist
Professor of Medicine (Cardiovascular Medicine)
Contact us to find out if this trial is right for you.
Contact
Research Nurse
650-725-2687
View on ClinicalTrials.gov
