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

NCT03227757 | Completed Results DMC FDA Device

• 1 other identifier: 16-517
• Study Type: interventional
• Target: 98
• Locations: 6 countries
• Sites: 20

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.

Conditions

Tricuspid Valve Insufficiency

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Tricuspid Valve Repair System

EXPERIMENTAL

Subjects who received TVRS will be included in this arm.

Device: Tricuspid Valve Repair System

Interventions

Tricuspid Valve Repair System 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.

Tricuspid Valve Repair System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be ≥18 years and ≤ 90 years at time of consent and must not be a member of a vulnerable population.
• Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
• Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.
• 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.
• New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV
• Subjects with moderate TR: Only NYHA Class III or IV may be considered
• No indication for left-sided or pulmonary valve correction.
• 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.
• In the judgement of the TVRS implanting investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
• 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).
• Tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team.
• Tricuspid valve anatomy evaluable by TTE and TEE.

You may not qualify if:

• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• 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.
• Severe uncontrolled hypertension (Systolic blood pressure \[SBP\] ≥ 180 mmHg and/or Diastolic blood pressure \[DBP\] ≥ 110 mm Hg).
• Systolic Pulmonary Artery Pressure \> 60 mmHg (echo determined).
• Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.
• Mitral Regurgitation moderate-severe or greater severity (≥3+).
• Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of TVRS Clip.
• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.
• Myocardial Infarction (MI) or known unstable angina within prior 30 days prior to enrollment.
• Percutaneous coronary intervention within prior 30 days prior to enrollment.
• 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.
• Cerebrovascular Accident (CVA) within prior 3 months to enrollment.
• Chronic dialysis.
• Bleeding disorders or hypercoagulable state.
• Active peptic ulcer or active gastrointestinal (GI) bleeding.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (20)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Hospital Nord Laennec - Chu De Nantes

Nantes, Saint-Herblain, 44 093, France

Location

Bichat-Claude Bernard Hospital

Paris, 75018, France

Location

Ludwig-Maximilian University of Munich (LMU)

Munich, Bavaria, 81377, Germany

Location

Schuchtermann Klinik

Bad Rothenfelde, Lower Saxony, 49214, Germany

Location

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Leipzig Heart Center

Leipzig, Saxony, 04289, Germany

Location

Albertinen-Krankenhaus

Hamburg, 22457, Germany

Location

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto

Catania, Catania (CT), 95124, Italy

Location

San Raffaele University Hospital

Milan, Milan, 20132, Italy

Location

Istituto Clinico Sant'Ambrogio

Milan, Milan, 20149, Italy

Location

Hospital de Sant Pau

Barcelona, 08025, Spain

Location

Clinical and Provincial Hospital of Barcelona

Barcelona, 08036, Spain

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

HerzKlinik Hirslanden - Klinik Hirslanden

Zurich, 8032, Switzerland

Location

University Hospital of Zurich (USZ)

Zurich, 8091, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 39243264 DERIVED

• 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.

  PMID: 37582170 DERIVED

• 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.

  PMID: 33478646 DERIVED

• 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.

  PMID: 31708188 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Karine Miquel
• Organization: Abbott

karine.miquel@abbott.com

+32 479 600 107

Study Officials

• Prof. Georg Nickenig

  University Hospital, Bonn

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: July 24, 2017
• Study Start: August 1, 2017
• Primary Completion: November 14, 2019
• Study Completion: May 30, 2024
• Last Updated: November 6, 2024
• Results First Posted: October 26, 2021

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3); DE (6); ES (2); IT (3); US (4); FR (2)