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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
Results First Posted : October 26, 2021
Last Update Posted : December 23, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Tricuspid Valve Insufficiency Device: Tricuspid Valve Repair System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : November 14, 2019
Estimated Study Completion Date : June 9, 2024

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.




Primary Outcome Measures :
  1. Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade [ Time Frame: At 30 days ]
    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.

  2. Number of Participants With Composite of Major Adverse Event (MAE) [ Time Frame: At 6 months ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227757


Locations
Show Show 20 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Prof. Georg Nickenig University Hospital, Bonn
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol  [PDF] February 1, 2018
Statistical Analysis Plan  [PDF] August 16, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03227757    
Other Study ID Numbers: 16-517
First Posted: July 24, 2017    Key Record Dates
Results First Posted: October 26, 2021
Last Update Posted: December 23, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Abbott Medical Devices:
TRILUMINATE
Percutaneous transcatheter intervention
Tricuspid regurgitation
Tricuspid Valve Repair System
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases