Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Symptomatic severe tricuspid valve regurgitation of primary or secondary etiology.
• NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.
• Subject is adequately treated with medical therapy for heart failure ≥ 30 days prior to
• index procedure, including a diuretic.
• Heart Team determines patient is a recommended candidate for the VDyne System.
• Age \>18 years at time of index procedure.
• Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.
Locations
United States
California
Los Robles Hospital and Medical Center
RECRUITING
Thousand Oaks
Michigan
Henry Ford Hospital
RECRUITING
Detriot
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
Mayo Clinic - Rochester
RECRUITING
Rochester
New York
Columbia University Medical Center/NYPH
NOT_YET_RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Oregon
Oregon Health and Science Unversity
RECRUITING
Portland
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Ascension St. Thomas
RECRUITING
Nashville
Other Locations
Canada
Québec-Université Laval (IUCPQ-ULaval)
RECRUITING
Québec
Contact Information
Primary
Jeya Satheesh
jsatheesh@vdyne.com
+1.952.686.8158
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2030-11-30
Participants
Target number of participants: 30
Treatments
Experimental: VDyne System Treatment Arm
Device
Related Therapeutic Areas
Sponsors
Leads: VDyne, Inc.