Tricuspid Regurgitation
Conditions
Brief summary
This study is prospective, multicentre, non-randomized single-arm early feasibility study to evaluate the safety and performance of the CroíValve DUO Transcatheter Tricuspid Coaptation Valve System in patients with severe Tricuspid Regurgitation.
Interventions
DEVICETranscatheter Tricuspid Valve Implantation
Implantation of a tricuspid coaptation valve 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 Tricuspid Regurgitation per American Society of Echocardiography (ASE) Criteria determined by Echo Core Lab assessment of a qualifying Transthoracic Echocardiogram (TTE). 2. Subject is symptomatic despite medical therapy (NYHA Functional Class II or higher) 3. Subject is on stable medical therapy as assessed by the Heart Team 4. The patient's anatomy is suitable in the judgment of the Investigational Site Heart Team and the Patient Screening Committee. 5. Age ≥18 years 6. The patient or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the EC of the respective clinical site.
Exclusion criteria
1. Subject is currently participating in another clinical investigation that could affect the outcome of this trial 2. Transesophageal echocardiography (TEE) is contraindicated or unsuccessful 3. Previous tricuspid valve repair, replacement or transcatheter tricuspid intervention 4. Moderate to severe tricuspid valve stenosis 5. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation 6. Significant comorbid factors which places the subject at prohibitive risk for surgical repair in the judgment of the Investigational Site Heart Team and the Patient Screening Committee 7. Need for concomitant surgical or interventional procedure known at time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair). 8. Ejection Fraction (EF) \<30% within 45 days of the implant procedure 9. Echocardiographic or CT evidence of intracardiac mass, thrombus or vegetation 10. Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg 11. Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices 12. Severe respiratory instability: Severe COPD or continuous use of home oxygen or has FEV1 \<50% of predicted 13. Severe right ventricular dysfunction as determined by the Echo Core Lab 14. Untreated clinically significant coronary artery disease requiring revascularization surgical or interventional PCI 15. Stroke or transient ischemic event within 90 days prior to the implant procedure 16. Untreated severe symptomatic carotid stenosis (\>70% by ultrasound) 17. Acute myocardial infarction within 30 days before the index procedure 18. Renal insufficiency (eGFR\<25 ml/min) 19. Active endocarditis within 6 months of the implant procedure 20. Pulmonary embolism within the last 6 months 21. Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure 22. Patient has an SVC dimension/anatomy is not suitable for device implantation (i.e., extremely tortuous, heavily calcified, aneurysmal) 23. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis 24. Life expectancy \<1 year 25. Active infections requiring current antibiotic therapy 26. Known severe liver disease 27. Prior heart or lung transplant 28. Known active peptic ulcer or active GI bleed 29. Unable to take anticoagulant therapy 30. Known patient is actively abusing drugs 31. Subjects who are pregnant or planning to become pregnant 32. Any condition making it unlikely the subject will be able to complete all protocol procedures (including compliance with guideline-directed medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result 33. Any known major coagulation abnormalities, thrombocytopenia, platelets \<50,0000/ml or anemia Hb \<9g/dl 34. Any known sensitivities or allergies to contrast and/or the device materials, including nickel and titanium 35. BMI \>50kg/m2 36. Transvalvular implanted pacemaker or ICD lead is present
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device or procedure related serious adverse events | Day 30 | Freedom from device or procedure related serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Test (6MWT) | Day 30, Month 6, Month 12 | Change in distance (m) from baseline |
| Change in TR Grade | Day 30, Month 6, Month 12 | Number of patients with reduction in TR from baseline as assessed by echocardiography |
| NHYA Functional Class | Day 30, Month 6, Month 12 | Number of patients with improvement in NYHA class |
Countries
Poland
Outcome results
None listed