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

Primary Purpose

Tricuspid Valve Insufficiency

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Tricuspid Valve Repair System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Valve Insufficiency focused on measuring TRILUMINATE, Percutaneous transcatheter intervention, Tricuspid regurgitation, Tricuspid Valve Repair System

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Henry Ford Hospital
  • Abbott Northwestern Hospital
  • Mount Sinai Hospital
  • Hospital Nord Laennec - Chu De Nantes
  • Bichat-Claude Bernard Hospital
  • Ludwig-Maximilian University of Munich (LMU)
  • Schuchtermann Klinik
  • University Hospital Bonn
  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
  • Leipzig Heart Center
  • Albertinen-Krankenhaus
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
  • San Raffaele University Hospital
  • Istituto Clinico Sant'Ambrogio
  • Hospital de Sant Pau
  • Clinical and Provincial Hospital of Barcelona
  • Inselspital Bern
  • HerzKlinik Hirslanden - Klinik Hirslanden
  • University Hospital of Zurich (USZ)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tricuspid Valve Repair System

Arm Description

Subjects who received TVRS will be included in this arm.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
June 20, 2017
Last Updated
January 24, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT03227757
Brief Title
TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
Acronym
TRILUMINATE
Official Title
Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
June 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Insufficiency
Keywords
TRILUMINATE, Percutaneous transcatheter intervention, Tricuspid regurgitation, Tricuspid Valve Repair System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tricuspid Valve Repair System
Arm Type
Experimental
Arm Description
Subjects who received TVRS will be included in this arm.
Intervention Type
Device
Intervention Name(s)
Tricuspid Valve Repair System
Intervention Description
Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
Primary Outcome Measure Information:
Title
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
Description
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.
Time Frame
At 30 days
Title
Number of Participants With Composite of Major Adverse Event (MAE)
Description
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
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion 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. Echocardiographic Inclusion Criteria: 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. Exclusion Criteria: 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. Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 4 weeks after discontinuation of antibiotics with no active infection). Known allergy or hypersensitivity to device materials. 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. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation. Life expectancy of less than 12 months due to non-cardiac conditions. Echocardiographic Exclusion Criteria: Tricuspid stenosis. Left Ventricular Ejection Fraction (LVEF) ≤20%. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include: Evidence of calcification in the grasping area Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Georg Nickenig
Organizational Affiliation
University Hospital, Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Hospital Nord Laennec - Chu De Nantes
City
Nantes
State/Province
Saint-Herblain
ZIP/Postal Code
44 093
Country
France
Facility Name
Bichat-Claude Bernard Hospital
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Ludwig-Maximilian University of Munich (LMU)
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Facility Name
Schuchtermann Klinik
City
Bad Rothenfelde
State/Province
Lower Saxony
ZIP/Postal Code
49214
Country
Germany
Facility Name
University Hospital Bonn
City
Bonn
State/Province
North Rhine-Westphalia
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
City
Mainz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
55131
Country
Germany
Facility Name
Leipzig Heart Center
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
Facility Name
Albertinen-Krankenhaus
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
City
Catania
State/Province
Catania (CT)
ZIP/Postal Code
95124
Country
Italy
Facility Name
San Raffaele University Hospital
City
Milano
State/Province
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Clinico Sant'Ambrogio
City
Milano
State/Province
Milan
ZIP/Postal Code
20149
Country
Italy
Facility Name
Hospital de Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Clinical and Provincial Hospital of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
HerzKlinik Hirslanden - Klinik Hirslanden
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
University Hospital of Zurich (USZ)
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33478646
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.
Results Reference
derived
PubMed Identifier
31708188
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. Erratum In: Lancet. 2020 Mar 14;395(10227):870.
Results Reference
derived

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

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