Heart Valve Diseases, Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valve Insufficiency
Conditions
Keywords
Transcatheter, Coaptation Valve, TR, SVC, Tricuspid
Brief summary
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).
Detailed description
Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.
Interventions
DEVICEDUO Transcatheter Tricuspid Coaptation Valve System
Reduction of tricuspid regurgitation through a transcatheter approach
Sponsors
CroiValve Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device or procedure related MAEs | At 30 days | * Death * Reintervention * Disabling stroke * Myocardial infarction * Major access site and vascular complications * Severe bleeding * Renal failure requiring dialysis * Major cardiac structural complications * Pulmonary embolism |
Countries
Poland, United States
Contacts
CONTACTHelen Scotch
CONTACTAubrey Dyer
Outcome results
None listed