Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
• Patient is symptomatic despite medical therapy.
• The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
• The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
• Age ≥18 years
• The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.
Locations
United States
Arizona
Dignity Health St. Joseph's Hospital & Medical Center
RECRUITING
Phoenix
California
Los Robles Hospital & Medical Center
RECRUITING
Thousand Oaks
Georgia
Piedmont Heart Institute
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Kansas
Ascension Via Christi Research
RECRUITING
Wichita
Minnesota
Allina Health Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
New York
Columbia University Medical Center/NYPH
RECRUITING
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
OhioHealth Research Institute
RECRUITING
Columbus
Pennsylvania
UPMC Pinnacle Harrisburg
RECRUITING
Harrisburg
Utah
Intermountain Health
RECRUITING
Salt Lake City
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Poland
Medical University of Silesia
RECRUITING
Katowice
Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu
RECRUITING
Poznan
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym
RECRUITING
Warsaw
Contact Information
Primary
Helen Scotch
Helen@CroiValve.com
612-229-9950
Backup
Aubrey Dyer
Aubrey@CroiValve.com
916-768-9141
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2029-10
Participants
Target number of participants: 15
Treatments
Experimental: Treatment
Treatment with the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System)
Related Therapeutic Areas
Sponsors
Leads: CroiValve Limited