RecruitingNot ApplicableNCT05913908

EFS of the DUO System for Tricuspid Regurgitation

Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System in Patients With Tricuspid Regurgitation

Sponsor

CroiValve Limited

Enrollment

15 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

Tricuspid Regurgitation Heart Valve Diseases Tricuspid Valve Insufficiency Tricuspid Valve Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called DUO Transcatheter Tricuspid Coaptation Valve System for people with heart valve diseases, tricuspid regurgitation, and other related conditions. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDUO Transcatheter Tricuspid Coaptation Valve System

Reduction of tricuspid regurgitation through a transcatheter approach

Locations(15)

Dignity Health St. Joseph's Hospital & Medical Center

Phoenix, Arizona, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Ascension Via Christi Research

Wichita, Kansas, United States

Allina Health Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Columbia University Medical Center/NYPH

New York, New York, United States

OhioHealth Research Institute

Columbus, Ohio, United States

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, United States

San Antonio Methodist

San Antonio, Texas, United States

Intermountain Health

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States

Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu

Poznan, Poznan, Poland

Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym

Warsaw, Warsaw, Poland

Medical University of Silesia

Katowice, Poland

View Full Details on ClinicalTrials.gov

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NCT05913908

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