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Evaluating the DUO System for treating Tricuspid Regurgitation

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

Not applicable Interventional CroiValve Limited · NCT05913908

This study is testing a new heart valve system to see if it can help people with severe tricuspid regurgitation feel better and improve their heart function.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment15 (estimated)
Ages18 Years and up
SexAll
SponsorCroiValve Limited Industry-sponsored
Locations16 sites (Phoenix, Arizona and 15 other locations)
Trial IDNCT05913908 on ClinicalTrials.gov

What this trial studies

This early feasibility study aims to assess the clinical outcomes and effectiveness of the DUO Transcatheter Tricuspid Coaptation Valve System in patients with severe tricuspid regurgitation. It is a multi-center, prospective, non-randomized investigation that will collect data on the safety and function of the device, as well as track clinical outcomes for up to five years. The study involves a thorough evaluation by a local Site Heart Team to determine patient eligibility based on their anatomy and symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with severe tricuspid regurgitation who remain symptomatic despite medical management.

Not a fit: Patients with moderate or greater tricuspid valve stenosis or those who have had previous tricuspid valve interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from severe tricuspid regurgitation who are symptomatic despite medical therapy.

How similar studies have performed: While this approach is investigational, similar transcatheter valve interventions have shown promise in other studies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
2. Patient is symptomatic despite medical therapy.
3. The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
4. The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
5. Age ≥18 years
6. The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.

Exclusion Criteria:

1. Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
2. Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
3. Moderate or greater tricuspid valve stenosis.
4. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
5. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
6. Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
7. Ejection Fraction (EF) \<25%
8. Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
9. Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg
10. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
11. Severe respiratory instability with continuous use of home oxygen
12. Severe right ventricular dysfunction
13. Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.
14. Stroke or transient ischemic event within 90 days prior to the index procedure
15. Acute myocardial infarction within 30 days before the index procedure
16. Renal insufficiency (eGFR \<25 ml/min) or currently on chronic dialysis
17. Active endocarditis within 6 months of the index procedure
18. Pulmonary embolism or deep vein thrombosis within the last 6 months
19. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
20. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
21. Life expectancy \<1 year
22. Active infections requiring current antibiotic therapy
23. Known severe liver disease
24. Is on the waiting list for a transplant or has had a prior heart or lung transplant
25. Known active peptic ulcer or active GI bleed
26. Unable to take anticoagulant therapy
27. Any known major coagulation abnormalities, thrombocytopenia, platelets \< 50,000/ml or severe anemia Hb \<8 g/dl
28. Known patient is actively abusing drugs
29. Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium
30. Patients who are pregnant or intend to become pregnant
31. Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result

Where this trial is running

Phoenix, Arizona and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Tricuspid RegurgitationTricuspid Valve InsufficiencyTricuspid Valve DiseaseHeart Valve DiseasesTranscatheterCoaptation ValveTRSVC
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.