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2019-06 TRISCEND Study
Not Recruiting
Trial ID: NCT04221490
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
Stanford Investigator(s)
Rahul P Sharma, MBBS, FRACP
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Jack Boyd
Clinical Associate Professor, Cardiothoracic Surgery
Christiane Haeffele
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Mirela Tuzovic
Clinical Assistant Professor, Medicine - Cardiovascular Medicine
Mayil Singram Krishnam
Clinical Professor, Radiology
David Lee, MD
Professor of Medicine (Cardiovascular Medicine)
Dominik Fleischmann
Professor of Radiology (Cardiovascular Imaging)
John W. MacArthur
Assistant Professor of Cardiothoracic Surgery (Adult Cardiac Surgery)
Eligibility
Key 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
Intervention(s):
device: Transcatheter Tricuspid Valve Replacement
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Research Nurse
650-725-2687