TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR

Overview

The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.

Full Title of Study: “Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2024

Detailed Description

This is a prospective, single arm, multi-center study.

A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years. Whereas, in United States patients will be followed-up till 5 years.

Interventions

  • Device: Tricuspid Valve Repair System
    • Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.

Arms, Groups and Cohorts

  • Experimental: Tricuspid Valve Repair System
    • Subjects who received TVRS will be included in this arm.

Clinical Trial Outcome Measures

Primary Measures

  • Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
    • Time Frame: At 30 days
    • Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
  • Composite of Major Adverse Event (MAE)
    • Time Frame: At 6 months
    • Composite of Major Adverse Event (MAE)

Secondary Measures

  • Composite of Major Adverse Event (MAE)
    • Time Frame: At Discharge (≤ 7 days post index procedure)
    • Composite of Major Adverse Event (MAE)
  • Composite of Major Adverse Event (MAE)
    • Time Frame: 30 days
    • Composite of Major Adverse Event (MAE)
  • Composite of Major Adverse Event (MAE)
    • Time Frame: 1 year
    • Composite of Major Adverse Event (MAE)
  • Composite of Major Adverse Event (MAE)
    • Time Frame: 2 years
    • Composite of Major Adverse Event (MAE)
  • Composite of Major Adverse Event (MAE)
    • Time Frame: 3 years
    • Composite of Major Adverse Event (MAE)
  • Prevalence of Device or Procedure-Related Adverse Events
    • Time Frame: 30 days
    • Prevalence of Device or Procedure-Related Adverse Events
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
    • Time Frame: 30 days
    • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
    • Time Frame: 6 months
    • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
    • Time Frame: 1 year
    • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
    • Time Frame: 2 years
    • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
    • Time Frame: 3 years
    • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade

Participating in This Clinical Trial

Inclusion Criteria

1. Subject must be 18 years and ≤ 90 years at time of consent and must not be a member of a vulnerable population.

2. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.

3. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.

4. In the judgment of the investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, mitral regurgitation and heart failure at least 30-days prior to index procedure. The Eligibility Committee must concur that the subject has been adequately treated.

5. New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV

1. Subjects with moderate TR: Only NYHA Class III or IV maybe considered for inclusion.

2. Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion.

6. No indication for left-sided or pulmonary valve correction.

7. The Site Heart Team concur the benefit-risk analysis supports intervention of Valvular heart disease and that the subject is at high risk for tricuspid valve surgery.

8. In the judgement of the TVRS implanting investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.

Echocardiographic Inclusion Criteria:

9. Subjects with moderate or greater (≥2+) Tricuspid Regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) confirmed by the Echocardiography Core Lab (ECL). Subjects with moderate TR will only be included in the trial if moderate TR is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by the site heart team echocardiographer. Note: Additional NYHA criteria for moderate TR patients(see Inclusion Criteria #5). Additional note: If any cardiac procedure(s) that may occur within 90-days of procedure, then TTE and TEE must be repeated prior to the index procedure.

10. Subjects with tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team

11. Subjects with tricuspid valve anatomy evaluable by TTE and TEE

Exclusion Criteria

1. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

2. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

3. Subjects with severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180 mmHg and/or Diastolic blood pressure [DBP] ≥ 110 mm Hg)

4. Subjects with Systolic Pulmonary Artery Pressure > 60 mmHg (echo determined)

5. Subjects with prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.

6. Subjects with Mitral Regurgitation moderate-severe or greater severity (≥3+)

7. Subjects with Pacemaker or ICD leads that would prevent appropriate placement of TVRS Clip

8. Subjects with active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.

9. Subjects with MI or known unstable angina within prior 30 days prior to enrollment

10. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment

11. Subjects with hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.

12. Subjects with Cerebrovascular Accident (CVA) within prior 3 months to enrollment

13. Subjects with chronic dialysis

14. Subjects with bleeding disorders or hypercoagulable state

15. Subjects with active peptic ulcer or active gastrointestinal (GI) bleeding

16. Subjects with contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.

17. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 4 weeks after discontinuation of antibiotics with no active infection).

18. Known allergy or hypersensitivity to device materials

19. In the judgement of the investigator, a condition that could limit a patient's ability or unwillingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study

20. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.

21. Subjects with life expectancy of less than 12 months due to non-cardiac conditions

Echocardiographic Exclusion Criteria:

22. Subjects with tricuspid stenosis

23. Left Ventricular Ejection Fraction (LVEF)≤20%

24. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:

1. Evidence of calcification in the grasping area

2. Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Prof. Georg Nickenig, Principal Investigator, University Hospital, Bonn

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