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

NCT ID: NCT03227757

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2024-05-30

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.

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.

Conditions

Tricuspid Valve Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tricuspid Valve Repair System

Subjects who received TVRS will be included in this arm.

Group Type: EXPERIMENTAL

Tricuspid Valve Repair System

Intervention Type: DEVICE

Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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 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.

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Georg Nickenig

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bonn

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Henry Ford Hospital

Detroit, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mount Sinai Hospital

New York, New York, United States

Hospital Nord Laennec - Chu De Nantes

Nantes, Saint-Herblain, France

Bichat-Claude Bernard Hospital

Paris, , France

Ludwig-Maximilian University of Munich (LMU)

Munich, Bavaria, Germany

Schuchtermann Klinik

Bad Rothenfelde, Lower Saxony, Germany

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Rhineland-Palatinate, Germany

Leipzig Heart Center

Leipzig, Saxony, Germany

Albertinen-Krankenhaus

Hamburg, , Germany

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto

Catania, Catania (CT), Italy

San Raffaele University Hospital

Milan, Milan, Italy

Istituto Clinico Sant'Ambrogio

Milan, Milan, Italy

Hospital de Sant Pau

Barcelona, , Spain

Clinical and Provincial Hospital of Barcelona

Barcelona, , Spain

Inselspital Bern

Bern, , Switzerland

HerzKlinik Hirslanden - Klinik Hirslanden

Zurich, , Switzerland

University Hospital of Zurich (USZ)

Zurich, , Switzerland

Countries

United States; France; Germany; Italy; Spain; Switzerland

References

Nickenig G, Lurz P, Sorajja P, von Bardeleben RS, Sitges M, Tang GHL, Hausleiter J, Trochu JN, Nabauer M, Heitkemper M, Ying SW, Weber M, Hahn RT; TRILUMINATE Investigators. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2113-2122. doi: 10.1016/j.jcin.2024.05.036. Epub 2024 Sep 4.

Reference Type: DERIVED

PMID: 39243264 (View on PubMed)

von Bardeleben RS, Lurz P, Sorajja P, Ruf T, Hausleiter J, Sitges M, Da Rocha E Silva J, Nabauer M, Weber M, Tang GHL, Heitkemper M, Ying SW, Trochu JN, Kar S, Hahn RT, Nickenig G; TRILUMINATE Trial Investigators. Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial. Circ Cardiovasc Interv. 2023 Aug;16(8):e012888. doi: 10.1161/CIRCINTERVENTIONS.122.012888. Epub 2023 Aug 15.

Reference Type: DERIVED

PMID: 37582170 (View on PubMed)

Lurz P, Stephan von Bardeleben R, Weber M, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Nabauer M, Tang GHL, Biaggi P, Ying SW, Trusty PM, Dahou A, Hahn RT, Nickenig G; TRILUMINATE Investigators. Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Jan 26;77(3):229-239. doi: 10.1016/j.jacc.2020.11.038.

Reference Type: DERIVED

PMID: 33478646 (View on PubMed)

Nickenig G, Weber M, Lurz P, von Bardeleben RS, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Nabauer 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.

Reference Type: DERIVED

PMID: 31708188 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

16-517

Identifier Type: -

Identifier Source: org_study_id