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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tricuspid Valve Insufficiency
• Intervention / Treatment: Device: Tricuspid Valve Repair System

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Bichat-Claude Bernard Hospital
  • Saint-Herblain
    • Nantes, Saint-Herblain, France, 44 093
      • Hospital Nord Laennec - Chu De Nantes
• Germany
  • Hamburg, Germany, 22457
    • Albertinen-Krankenhaus
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Ludwig-Maximilian University of Munich (LMU)
  • Lower Saxony
    • Bad Rothenfelde, Lower Saxony, Germany, 49214
      • Schüchtermann Klinik
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • University Hospital Bonn
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Leipzig Heart Center
• Italy
  • Catania (CT)
    • Catania, Catania (CT), Italy, 95124
      • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
  • Milan
    • Milano, Milan, Italy, 20132
      • San Raffaele University Hospital
    • Milano, Milan, Italy, 20149
      • Istituto Clinico Sant'Ambrogio
• Spain
  • Barcelona, Spain, 08025
    • Hospital de Sant Pau
  • Barcelona, Spain, 08036
    • Clinical and Provincial Hospital of Barcelona
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Zurich, Switzerland, 8032
    • HerzKlinik Hirslanden - Klinik Hirslanden
  • Zurich, Switzerland, 8091
    • University Hospital of Zurich (USZ)
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Prof. Georg Nickenig, University Hospital, Bonn

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Lancet. 2020 Mar 14;395(10227):870.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 14, 2019
• Study Completion (Estimated): June 9, 2024

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Tricuspid regurgitation; TRILUMINATE; Percutaneous transcatheter intervention; Tricuspid Valve Repair System
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 16-517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes