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

• ClinicalTrials.gov Identifier: NCT03227757
• Recruitment Status: Active, not recruiting
• First Posted: July 24, 2017
• Last Update Posted: July 28, 2020
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Tricuspid Valve Insufficiency	Device: Tricuspid Valve Repair System	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 98 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
• Actual Study Start Date: August 1, 2017
• Estimated Primary Completion Date: November 30, 2024
• Estimated Study Completion Date: March 30, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tricuspid Valve Repair System; Subjects who received TVRS will be included in this arm.	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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Composite of Major Adverse Event (MAE) [ Time Frame: At Discharge (≤ 7 days post index procedure) ]
   Composite of Major Adverse Event (MAE)
2. Composite of Major Adverse Event (MAE) [ Time Frame: 30 days ]
   Composite of Major Adverse Event (MAE)
3. Composite of Major Adverse Event (MAE) [ Time Frame: 1 year ]
   Composite of Major Adverse Event (MAE)
4. Composite of Major Adverse Event (MAE) [ Time Frame: 2 years ]
   Composite of Major Adverse Event (MAE)
5. Composite of Major Adverse Event (MAE) [ Time Frame: 3 years ]
   Composite of Major Adverse Event (MAE)
6. Prevalence of Device or Procedure-Related Adverse Events [ Time Frame: 30 days ]
   Prevalence of Device or Procedure-Related Adverse Events
7. 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
8. 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
9. 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
10. 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
11. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

United States, Michigan

Henry Ford Hospital

Detroit, Michigan, United States, 48202

United States, Minnesota

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

United States, New York

Mount Sinai Hospital

New York, New York, United States, 10029

France

Hospital Nord Laennec - Chu De Nantes

Nantes, Saint-Herblain, France, 44 093

Bichat-Claude Bernard Hospital

Paris, France, 75018

Germany

Ludwig-Maximilian University of Munich (LMU)

Munich, Bavaria, Germany, 81377

Schuchtermann Klinik

Bad Rothenfelde, Lower Saxony, Germany, 49214

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany, 53127

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Rhineland-Palatinate, Germany, 55131

Leipzig Heart Center

Leipzig, Saxony, Germany, 04289

Albertinen-Krankenhaus

Hamburg, Germany, 22457

Italy

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto

Catania, Catania (CT), Italy, 95124

San Raffaele University Hospital

Milano, Milan, Italy, 20132

Istituto Clinico Sant'Ambrogio

Milano, Milan, Italy, 20149

Spain

Hospital de Sant Pau

Barcelona, Spain, 08025

Clinical and Provincial Hospital of Barcelona

Barcelona, Spain, 08036

Switzerland

Inselspital Bern

Bern, Switzerland, 3010

HerzKlinik Hirslanden - Klinik Hirslanden

Zurich, Switzerland, 8032

University Hospital of Zurich (USZ)

Zurich, Switzerland, 8091

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Principal Investigator: Prof. Georg Nickenig; University Hospital, Bonn

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nickenig G, Weber M, Lurz P, von Bardeleben RS, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Näbauer M, Dahou A, Hahn RT. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet. 2019 Nov 30;394(10213):2002-2011. doi: 10.1016/S0140-6736(19)32600-5. Epub 2019 Nov 7. Erratum in: Lancet. 2020 Mar 14;395(10227):870.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03227757
• Other Study ID Numbers: 16-517
• First Posted: July 24, 2017
• Last Update Posted: July 28, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Abbott Medical Devices:

TRILUMINATE; Percutaneous transcatheter intervention; Tricuspid regurgitation; Tricuspid Valve Repair System

Additional relevant MeSH terms:

Tricuspid Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases