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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03227757
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE July 24, 2017
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade [ Time Frame: At 30 days ]
    Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
  • Composite of Major Adverse Event (MAE) [ Time Frame: At 6 months ]
    Composite of Major Adverse Event (MAE)
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade [ Time Frame: At 30 days ]
  • Composite of Major Adverse Event (MAE) [ Time Frame: At 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2020)
  • Composite of Major Adverse Event (MAE) [ Time Frame: At Discharge (≤ 7 days post index procedure) ]
    Composite of Major Adverse Event (MAE)
  • Composite of Major Adverse Event (MAE) [ Time Frame: 30 days ]
    Composite of Major Adverse Event (MAE)
  • Composite of Major Adverse Event (MAE) [ Time Frame: 1 year ]
    Composite of Major Adverse Event (MAE)
  • Composite of Major Adverse Event (MAE) [ Time Frame: 2 years ]
    Composite of Major Adverse Event (MAE)
  • Composite of Major Adverse Event (MAE) [ Time Frame: 3 years ]
    Composite of Major Adverse Event (MAE)
  • Prevalence of Device or Procedure-Related Adverse Events [ Time Frame: 30 days ]
    Prevalence of Device or Procedure-Related Adverse Events
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 30 days ]
    Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 6 months ]
    Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 1 year ]
    Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 2 years ]
    Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 3 years ]
    Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • Composite of Major Adverse Event (MAE) [ Time Frame: At Discharge (≤ 7 days post index procedure) ]
  • Composite of Major Adverse Event (MAE) [ Time Frame: 30 days ]
  • Composite of Major Adverse Event (MAE) [ Time Frame: 1 year ]
  • Composite of Major Adverse Event (MAE) [ Time Frame: 2 years ]
  • Composite of Major Adverse Event (MAE) [ Time Frame: 3 years ]
  • Prevalence of Device or Procedure-Related Adverse Events [ Time Frame: 30 days ]
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 30 days ]
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 6 months ]
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 1 year ]
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 2 years ]
  • Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
Official Title  ICMJE Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
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. Whereas, in United States patients will be followed-up till 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tricuspid Valve Insufficiency
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Tricuspid Valve Repair System
Subjects who received TVRS will be included in this arm.
Intervention: Device: Tricuspid Valve Repair System
Publications * Nickenig G, Weber M, Lurz P, von Bardeleben RS, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Näbauer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 27, 2020)
98
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2017)
75
Estimated Study Completion Date  ICMJE March 30, 2025
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 maybe considered for inclusion.
    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 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. Subjects with 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). Subjects with moderate TR will only be included in the trial if moderate TR is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by the site heart team echocardiographer. Note: Additional NYHA criteria for moderate TR patients(see Inclusion Criteria #5). Additional note: If any cardiac procedure(s) that may occur within 90-days of procedure, then TTE and TEE must be repeated prior to the index procedure.
  10. Subjects with tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team
  11. Subjects with 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. Subjects with severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180 mmHg and/or Diastolic blood pressure [DBP] ≥ 110 mm Hg)
  4. Subjects with Systolic Pulmonary Artery Pressure > 60 mmHg (echo determined)
  5. Subjects with prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.
  6. Subjects with Mitral Regurgitation moderate-severe or greater severity (≥3+)
  7. Subjects with Pacemaker or ICD leads that would prevent appropriate placement of TVRS Clip
  8. Subjects with active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.
  9. Subjects with MI or known unstable angina within prior 30 days prior to enrollment
  10. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment
  11. Subjects with 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. Subjects with Cerebrovascular Accident (CVA) within prior 3 months to enrollment
  13. Subjects with chronic dialysis
  14. Subjects with bleeding disorders or hypercoagulable state
  15. Subjects with active peptic ulcer or active gastrointestinal (GI) bleeding
  16. Subjects with 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. Subjects with life expectancy of less than 12 months due to non-cardiac conditions

    Echocardiographic Exclusion Criteria:

  22. Subjects with 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03227757
Other Study ID Numbers  ICMJE 16-517
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Prof. Georg Nickenig University Hospital, Bonn
PRS Account Abbott Medical Devices
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP