EFS of the DUO System for Tricuspid Regurgitation

Recruiting now · Not applicable

Conditions studied: Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases

In brief

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).

Key facts

Study ID

NCT05913908

Run by

CroiValve Limited

People needed

15

Starts

2024-08-13

Expected to finish

2029-10-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
• Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
• Moderate or greater tricuspid valve stenosis.
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
• Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
• Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
• Ejection Fraction (EF) <25%
• Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
• Patient has Systolic Pulmonary Pressure (sPAP) >60 mm Hg
• Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
• Severe respiratory instability with continuous use of home oxygen
• Severe right ventricular dysfunction
• Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.
• Stroke or transient ischemic event within 90 days prior to the index procedure
• Acute myocardial infarction within 30 days before the index procedure
• Renal insufficiency (eGFR <25 ml/min) or currently on chronic dialysis
• Active endocarditis within 6 months of the index procedure
• Pulmonary embolism or deep vein thrombosis within the last 6 months
• Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
• Life expectancy <1 year
• Active infections requiring current antibiotic therapy
• Known severe liver disease
• Is on the waiting list for a transplant or has had a prior heart or lung transplant
• Known active peptic ulcer or active GI bleed

Where it is running

• Medical University of Silesia — Katowice, Poland (enrolling)
• Los Robles Hospital & Medical Center — Thousand Oaks, California, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Ascension Via Christi Research — Wichita, Kansas, United States (enrolling)
• Allina Health Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• Columbia University Medical Center/NYPH — New York, New York, United States (enrolling)
• OhioHealth Research Institute — Columbus, Ohio, United States (enrolling)
• UPMC Pinnacle Harrisburg — Harrisburg, Pennsylvania, United States (enrolling)
• Dignity Health St. Joseph's Hospital & Medical Center — Phoenix, Arizona, United States (enrolling)
• Intermountain Health — Salt Lake City, Utah, United States (enrolling)
• University of Washington — Seattle, Washington, United States (enrolling)
• Uniwersytetem Medycznym im. Karola Marcinkowskiego w Poznaniu — Poznan, Poznan, Poland (enrolling)
• Narodowym Instytutem Kardiologii Stefana Kardynała Wyszyńskiego - Państwowym Instytutem Badawczym — Warsaw, Warsaw, Poland (enrolling)
• San Antonio Methodist — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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