Clinical trial NCT04936802: Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)
Official title: Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Tricuspid valve repair
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate safety and feasibility of the transcatheter tricuspid valve repair system (Trialign) for the treatment or reduction of moderate to severe functional tricuspid regurgitation.

Detailed description: This study is a prospective single-arm trial for transcatheter tricuspid valve repair system (Trialign). A series of physical, imaging and laboratory exams will be performed to determine whether a subject has moderate to severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receiveTrialign treatment if an informed consent is obtained.

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.

Primary outcomes:
measure: Severe adverse device events (SADE)
timeFrame: 30 days
Secondary outcomes:
measure: Technical success
timeFrame: 30 days
measure: Evaluation of tricuspid valve function
timeFrame: 6 months
measure: New York Heart Association (NYHA) classification
timeFrame: 6 months
measure: 6-minute walk test (6MWT)
timeFrame: 6 months
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: 6 months
measure: Incidence of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Ling Tao
role: PRINCIPAL_INVESTIGATOR
References: