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

Tricuspid Valve Insufficiency Clinical Trial

— TRILUMINATE  

Official title:

Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03227757
• Other study ID #: 16-517
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 9, 2024

Study information

• Verified date: January 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: June 9, 2024
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 may be considered

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 for tricuspid regurgitation per current guidelines for the management 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. 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).

10. Tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team.

11. 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. Severe uncontrolled hypertension (Systolic blood pressure [SBP] = 180 mmHg and/or Diastolic blood pressure [DBP] = 110 mm Hg).

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

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

6. Mitral Regurgitation moderate-severe or greater severity (=3+).

7. Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of TVRS Clip.

8. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.

9. Myocardial Infarction (MI) or known unstable angina within prior 30 days prior to enrollment.

10. Percutaneous coronary intervention within prior 30 days prior to enrollment.

11. 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. Cerebrovascular Accident (CVA) within prior 3 months to enrollment.

13. Chronic dialysis.

14. Bleeding disorders or hypercoagulable state.

15. Active peptic ulcer or active gastrointestinal (GI) bleeding.

16. 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. Life expectancy of less than 12 months due to non-cardiac conditions.

Echocardiographic Exclusion Criteria:

22. 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

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	Hospital Nord Laennec - Chu De Nantes	Nantes	Saint-Herblain
France	Bichat-Claude Bernard Hospital	Paris
Germany	Schuchtermann Klinik	Bad Rothenfelde	Lower Saxony
Germany	University Hospital Bonn	Bonn	North Rhine-Westphalia
Germany	Albertinen-Krankenhaus	Hamburg
Germany	Leipzig Heart Center	Leipzig	Saxony
Germany	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz	Mainz	Rhineland-Palatinate
Germany	Ludwig-Maximilian University of Munich (LMU)	Munich	Bavaria
Italy	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto	Catania	Catania (CT)
Italy	Istituto Clinico Sant'Ambrogio	Milano	Milan
Italy	San Raffaele University Hospital	Milano	Milan
Spain	Clinical and Provincial Hospital of Barcelona	Barcelona
Spain	Hospital de Sant Pau	Barcelona
Switzerland	Inselspital Bern	Bern
Switzerland	HerzKlinik Hirslanden - Klinik Hirslanden	Zurich
Switzerland	University Hospital of Zurich (USZ)	Zurich
United States	Henry Ford Hospital	Detroit	Michigan
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade	Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.	At 30 days
Primary	Number of Participants With Composite of Major Adverse Event (MAE)	Major Adverse Event (MAE) is defined as a composite of: Cardiovascular Mortality; Myocardial Infarction (MI); Stroke; New onset renal failure; Endocarditis requiring surgery, and; Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure	At 6 months