Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT04936802
Eligibility Criteria:
Inclusion Criteria:
1. Subjects has been informed the study and provided written informed consent.
2. Age ≥ 18 and ≤ 85 years old.
3. NYHA class II, III or ambulatory IV.
4. The subject was diagnosed moderate to severe functional tricuspid regurgitation
5. The subject was at high risk for open heart valve surgery. The heart team recommended tricuspid annuloplasty.
6. Subjects shall meet all selected criteria for TEE with moderate or severe tricuspid regurgitation.
1. Systolic pulmonary artery pressure (SPAP) ≤ 60mmHg.
2. Left ventricular ejection fraction (LVEF) ≥ 30%.
3. Right ventricle tricuspid annular plane systolic excursion (TAPSE) ≥ 15 mm.
4. Tricuspid valve annular diameter ≤ 55 mm.
5. Tricuspid EROA ≤ 1.75 cm2.
6. Functional tricuspid valve regurgitation pathology with a structurally normal valve.
7. Sufficient posterior annular dimension for device implantation.
Exclusion Criteria:
1. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg).
2. History of heart transplant.
3. Previous tricuspid valve repair or replacement (including artificial valve).
4. Presence of a left ventricular assist device.
5. Active endocarditis.
6. Severe degenerative tricuspid valve disease.
7. Severe aortic stenosis.
8. The degree of mitral regurgitation is greater than grade 3.
9. Complete occlusion due to chronic calcification of the right coronary artery.
10. History of right internal jugular vein occlusion or thrombosis;
11. Anatomy in the region of the access path (right internal jugular vein) prevented correct placement of a percutaneous tricuspid valve annuloplasty system (e.g.: the presence of spinal stenosis, stent, vascular prosthesis).
12. An indication of the presence of thrombi in the right ventricle or atrium.
13. Myocardial infarction (MI) or known unstable angina within the 30 days prior to the index procedure.
14. Any percutaneous coronary intervention (PCI) within 30 days prior to the index procedure or planned 3 months post-the index procedure.
15. Hemodynamic instability or cardiogenic shock.
16. Restrictive or hypertrophic cardiomyopathy. Constructive pericarditis, or other structural heart disease.
17. Cerebrovascular accident (CVA) within the past 6 months
18. Serum creatinine \> 2.5 mg/dL (or 221 μmol/L), Impaired kidney function, defined as glomerular filtration rate (GFR) of 30 mL/min or less.
19. Anemia (hemoglobin \<\<90g/L) not corrected by transfusion. Thrombocytopenia (platelet count \<100×109/L) or thrombocytosis (\>750×109/L).
20. Bleeding disorders or hypercoagulable state.
21. Active peptic ulcer or active gastrointestinal bleeding.
22. Contraindication to anticoagulant or antiplatelet therapies.
23. Contraindications to or refusal of blood transfusions.
24. Known allergy to stainless steel, nickel, platinum iridium, polyester and/or silk.
25. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure.
26. Life expectancy less than 12 months.
27. Concurrent use of another clinical study product or use of another clinical study product within 30 days prior to enrolment.
28. Other circumstances deemed unsuitable for inclusion by the researcher.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04936802
Study Brief:
Protocol Section:
NCT04936802