Actively Recruiting
EFS of the DUO System for Tricuspid Regurgitation
Led by CroiValve Limited · Updated on 2026-05-13
15
Participants Needed
16
Research Sites
267 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 according to the Patient Selection Committee
- Age 18 years or older
- Patient has been informed about the study and has provided written informed consent
You will not qualify if you...
- Currently participating in another clinical trial that could affect this study'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
- Pacemaker or ICD leads preventing device placement
- Need for other surgical or interventional procedures known at screening
- Ejection fraction below 25%
- Unstable intracardiac mass, thrombus, or vegetation seen on echocardiogram
- Systolic pulmonary pressure over 60 mm Hg
- Severe hemodynamic instability requiring advanced support
- Severe respiratory instability with continuous home oxygen use
- Severe right ventricular dysfunction
- Untreated significant coronary or carotid artery disease needing revascularization
- Stroke or transient ischemic attack within 90 days before 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 before procedure
- Pulmonary embolism or deep vein thrombosis in last 6 months
- Any surgical, interventional, or transcatheter procedure within 30 days before procedure
- Hypertrophic, restrictive cardiomyopathy, or constrictive pericarditis
- Life expectancy less than 1 year
- Active infections needing antibiotics
- Known severe liver disease
- On waiting list for or prior heart or lung transplant
- Active peptic ulcer or gastrointestinal bleeding
- Unable to take anticoagulant therapy
- Major coagulation abnormalities, thrombocytopenia, or severe anemia
- Active drug abuse
- Known allergies to contrast agents or device materials
- Pregnant or planning pregnancy
- 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
Trial Site Locations
Total: 16 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
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
9
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
10
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States, 17050
Actively Recruiting
11
San Antonio Methodist
San Antonio, Texas, United States, 78229
Enrolling by Invitation
12
Intermountain Health
Salt Lake City, Utah, United States, 84111
Actively Recruiting
13
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
14
Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu
Poznan, Poznan, Poland, 60-355
Actively Recruiting
15
Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym
Warsaw, Warsaw, Poland, 04-628
Actively Recruiting
16
Medical University of Silesia
Katowice, Poland, 40-635
Actively Recruiting
Research Team
H
Helen Scotch
CONTACT
A
Aubrey Dyer
CONTACT
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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