Clinical trial NCT03227757: TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
Official title: Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Keywords: TRILUMINATE
Percutaneous transcatheter intervention
Tricuspid regurgitation
Tricuspid Valve Repair System
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-07-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

   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

Primary outcomes:
measure: Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
timeFrame: At 30 days
measure: Number of Participants With Composite of Major Adverse Event (MAE)
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Nantes
country: France
facility: Hospital Nord Laennec - Chu De Nantes
state: Saint-Herblain
city: Paris
country: France
facility: Bichat-Claude Bernard Hospital
city: Munich
country: Germany
facility: Ludwig-Maximilian University of Munich (LMU)
state: Bavaria
city: Bad Rothenfelde
country: Germany
facility: Schuchtermann Klinik
state: Lower Saxony
city: Bonn
country: Germany
facility: University Hospital Bonn
state: North Rhine-Westphalia
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
state: Rhineland-Palatinate
city: Leipzig
country: Germany
facility: Leipzig Heart Center
state: Saxony
city: Hamburg
country: Germany
facility: Albertinen-Krankenhaus
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
state: Catania (CT)
city: Milano
country: Italy
facility: San Raffaele University Hospital
state: Milan
city: Milano
country: Italy
facility: Istituto Clinico Sant'Ambrogio
state: Milan
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Clinical and Provincial Hospital of Barcelona
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Zurich
country: Switzerland
facility: HerzKlinik Hirslanden - Klinik Hirslanden
city: Zurich
country: Switzerland
facility: University Hospital of Zurich (USZ)
Study officials:
affiliation: University Hospital, Bonn
name: Prof. Georg Nickenig
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.