Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)

Tricuspid Regurgitation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04936802
• Other study ID #: Trialign study
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2021
• Source: Xijing Hospital
• Contact: Bo Wang
• Phone: 86-18092798759
• Email: trialign[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Transcatheter tricuspid valve repair system (Trialign)
To assess the Trialign System to treat subjects with moderate to severe tricuspid regurgitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe adverse device events (SADE)	Severe adverse device events (SADE) , defined as any device related complication, including but not limited to: death, myocardial infarction, stroke, reoperation, renal failure, pulmonary embolism, gastrointestinal bleeding, readmission, etc.	30 days
Secondary	Technical success	Technical success, defined as freedom from death with: Successful access, delivery and retrieval of the device delivery system; Deployment and correct positioning of the intended device(s) which is maintained and; No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.	30 days
Secondary	Evaluation of tricuspid valve function		6 months
Secondary	New York Heart Association (NYHA) classification		6 months
Secondary	6-minute walk test (6MWT)		6 months
Secondary	EuroQol five dimensions questionnaire (EQ-5D)		6 months
Secondary	Incidence of adverse events		6 months