Actively Recruiting
Early Feasibility Study of the DUO Transcatheter Tricuspid Coaptation Valve System for Tricuspid Regurgitation
Led by CroiValve Limited · Updated on 2026-06-01
15
Participants Needed
15
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System) in patients with severe tricuspid regurgitation who remain symptomatic despite medical therapy. This early feasibility study aims to measure individual patient clinical outcomes, assess the safety and function of the DUO System, and collect data on up to 5 years of clinical results. The study is multi-center, prospective, non-randomized, and conducted before market approval to gather key information about the device's performance. Participants will receive treatment with the DUO System, which is designed to reduce tricuspid regurgitation through a transcatheter approach. The study does not randomize or blind participants and focuses on evaluating the investigational device's safety and function. The treatment period includes initial device implantation and monitoring, with follow-up visits planned to assess both short-term and long-term outcomes. During the study, participants will undergo evaluations to monitor device safety, function, and clinical outcomes, including assessments of freedom from major adverse events related to the device or procedure at 30 days. Researchers will collect clinical data over a period that may extend to 5 years to understand the device's effectiveness and safety profile. Participants will be monitored regularly through clinical visits and assessments to ensure comprehensive data collection and safety oversight throughout the study period.
CONDITIONS
Brief Title
EFS of the DUO System for Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab
- Patient is symptomatic despite medical therapy
- Patient is deemed appropriate for transcatheter valve intervention by the local Site Heart Team
- Patient's anatomy is suitable as judged by the Patient Selection Committee
- Age 18 years or older
- Patient has provided written informed consent after being informed of the study's nature
You will not qualify if you...
- Currently participating in another clinical investigation that could affect this trial's outcome
- Previous tricuspid valve intervention that interferes with device placement
- Moderate or greater tricuspid valve stenosis
- Severe stenosis or regurgitation of aortic, mitral, or pulmonic valves
- Presence of pacemaker or ICD leads preventing device placement
- Need for additional surgical or interventional procedures known at screening
- Ejection fraction below 25%
- Unstable intracardiac mass, thrombus, or vegetation
- Systolic pulmonary pressure above 60 mm Hg
- Severe hemodynamic instability or need for advanced circulatory support
- Severe respiratory instability requiring continuous home oxygen
- Severe right ventricular dysfunction
- Untreated significant coronary or carotid artery disease needing revascularization
- Stroke or transient ischemic attack within 90 days prior to procedure
- Acute myocardial infarction within 30 days before procedure
- Renal insufficiency with eGFR below 25 ml/min or on chronic dialysis
- Active endocarditis within 6 months
- Pulmonary embolism or deep vein thrombosis within last 6 months
- Any surgical or interventional procedure within 30 days before procedure
- Hypertrophic, restrictive cardiomyopathy, or constrictive pericarditis
- Life expectancy less than 1 year
- Active infections requiring antibiotics
- Severe liver disease
- On transplant waiting list or prior heart/lung transplant
- Active peptic ulcer or gastrointestinal bleeding
- Unable to take anticoagulant therapy
- Major coagulation abnormalities or severe anemia
- Active drug abuse
- Allergies or sensitivities to contrast or device materials
- Pregnant or intending to become pregnant
- Conditions preventing completion of protocol procedures or follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate recovery period
Participants receive the DUO Transcatheter Tricuspid Coaptation Valve System through a transcatheter approach to reduce tricuspid regurgitation.
1 procedure visit and approximately 6 post-operative visits
Duration - Up to 5 years
Participants are monitored for safety and device function with clinical assessments and follow-up visits extending up to 5 years.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 15 locations
1
Dignity Health St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
3
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Ascension Via Christi Research
Wichita, Kansas, United States, 67214
Actively Recruiting
6
Allina Health Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
7
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
8
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
9
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States, 17050
Actively Recruiting
10
San Antonio Methodist
San Antonio, Texas, United States, 78229
Enrolling by Invitation
11
Intermountain Health
Salt Lake City, Utah, United States, 84111
Actively Recruiting
12
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
13
Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu
Poznan, Poznan, Poland, 60-355
Actively Recruiting
14
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym
Warsaw, Warsaw, Poland, 04-628
Actively Recruiting
15
Medical University of Silesia
Katowice, Poland, 40-635
Actively Recruiting
Research Team
H
Helen Scotch
A
Aubrey Dyer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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