Evaluating the DUO System for treating Tricuspid Regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Dignity Health St. Joseph's Hospital & Medical Center
  Phoenix, Arizona, United States Recruiting
• Los Robles Hospital & Medical Center
  Thousand Oaks, California, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Ascension Via Christi Research
  Wichita, Kansas, United States Recruiting
• MaineHealth Institute for Research
  Scarborough, Maine, United States Recruiting

Study contacts

• Study coordinator: Helen Scotch
• Email: Helen@CroiValve.com
• Phone: 612-229-9950

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

  This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.

  Recruiting at 12 sites VDyne, Inc. · Phoenix, Arizona and 11 other locations · NCT07516444

• Investigating multiple and mixed heart valve diseases

  This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06235385

• Follow-up of patients treated with TricValve® for heart valve issues

  This study follows patients who have had treatment for severe tricuspid regurgitation using the TricValve® system to see how well the valve is working over the next five years.

  Recruiting at 12 sites P+F Products + Features GmbH · Sankt Pölten, Lower Austria and 27 other locations · NCT05114850

• Transcatheter valve repair for severe tricuspid regurgitation

  This study is testing a new valve repair system to see if it helps people with severe tricuspid regurgitation feel better compared to just taking their medications.

  Recruiting at 45 sites Edwards Lifesciences · Phoenix, Arizona and 78 other locations · NCT04097145

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.