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

Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter tricuspid valve repair system (Trialign)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Wang; Phone Number: 86-18092798759; Email: trialign@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transcatheter tricuspid valve repair system (Trialign); Subjects who received transcatheter tricuspid valve repair with Trialign will be included in this arm.	Device: Transcatheter tricuspid valve repair system (Trialign); To assess the Trialign System to treat subjects with moderate to severe tricuspid regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events		6 months
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
Evaluation of tricuspid valve function		6 months
New York Heart Association (NYHA) classification		6 months
6-minute walk test (6MWT)		6 months
EuroQol five dimensions questionnaire (EQ-5D)		6 months

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 25, 2021
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (ACTUAL): June 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: Trialign study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No