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Evaluation of Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE) (TRILUMINATE)

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ClinicalTrials.gov Identifier: NCT03227757
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
Evalve

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. Whereas, in United States patients will be followed-up till 5 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
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
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : August 31, 2023

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. Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade [ Time Frame: At 30 days ]
  2. Composite of Major Adverse Event (MAE) [ Time Frame: At 6 months ]

Secondary Outcome Measures :
  1. Composite of Major Adverse Event (MAE) [ Time Frame: At Discharge (≤ 7 days post index procedure) ]
  2. Composite of Major Adverse Event (MAE) [ Time Frame: 30 days ]
  3. Composite of Major Adverse Event (MAE) [ Time Frame: 1 year ]
  4. Composite of Major Adverse Event (MAE) [ Time Frame: 2 years ]
  5. Composite of Major Adverse Event (MAE) [ Time Frame: 3 years ]
  6. Prevalence of Device or Procedure-Related Adverse Events [ Time Frame: 30 days ]
  7. Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 30 days ]
  8. Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 6 months ]
  9. Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 1 year ]
  10. Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 2 years ]
  11. Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 3 years ]


Information from the National Library of Medicine

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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 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

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


Contacts
Contact: Nadia Bouhdi 479 94 10 37 ext +32 nadia.bouhdi@av.abbott.com
Contact: Mike Hsu mike.hsu@abbott.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Dr. Saibal Kar         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Dr. Adam Greenbaum         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Principal Investigator: Dr. Paul Sorajja         
United States, New York
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Principal Investigator: Dr. Gilbert Tang         
France
Hospital Nord Laennec - Chu De Nantes Recruiting
Nantes, Saint-Herblain, France, 44 093
Principal Investigator: Prof. Patrice Guerin         
Bichat-Claude Bernard Hospital Recruiting
Paris, France, 75018
Principal Investigator: Dr. Jean-Michel Juliard         
Germany
Ludwig-Maximilian University of Munich (LMU) Recruiting
Munich, Bavaria, Germany, 81377
Principal Investigator: Prof. Jorg Hausleiter         
Schuchtermann Klinik Recruiting
Bad Rothenfelde, Lower Saxony, Germany, 49214
Principal Investigator: Dr. Marek Kowalski         
University Hospital Bonn Recruiting
Bonn, North Rhine-Westphalia, Germany, 53127
Principal Investigator: Prof. Georg Nickenig         
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Recruiting
Mainz, Rhineland-Palatinate, Germany, 55131
Principal Investigator: Dr. Ralph Stephan von Bardeleben         
Leipzig Heart Center Recruiting
Leipzig, Saxony, Germany, 04289
Principal Investigator: Prof. Philipp Lurz         
Albertinen-Krankenhaus Recruiting
Hamburg, Germany, 22457
Principal Investigator: Prof. Joachim Schofer         
Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto Recruiting
Catania, Catania (CT), Italy, 95124
Principal Investigator: Prof. Corrado Tamburino         
San Raffaele University Hospital Recruiting
Milano, Milan, Italy, 20132
Principal Investigator: Prof. Antonio Colombo         
Principal Investigator: Dr. Denti Paolo         
Istituto Clinico Sant'Ambrogio Recruiting
Milano, Milan, Italy, 20149
Principal Investigator: Dr. Francesco Bedogni         
Spain
Hospital de Sant Pau Recruiting
Barcelona, Spain, 08025
Principal Investigator: Prof. Antonio Serra         
Clinical and Provincial Hospital of Barcelona Recruiting
Barcelona, Spain, 08036
Principal Investigator: Dr. Marta Sitges         
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Principal Investigator: Prof. Stephan Windecker         
HerzKlinik Hirslanden - Klinik Hirslanden Recruiting
Zurich, Switzerland, 8032
Principal Investigator: Prof. Roberto Corti         
University Hospital of Zurich (USZ) Recruiting
Zurich, Switzerland, 8091
Principal Investigator: Prof. Maurizio Taramasso         
Sponsors and Collaborators
Evalve
Abbott Vascular
Investigators
Principal Investigator: Prof. Georg Nickenig University Hospital, Bonn

Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT03227757     History of Changes
Other Study ID Numbers: 16-517
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Evalve:
TRILUMINATE
Percutaneous transcatheter intervention
Tricuspid regurgitation
Tricuspid Valve Repair System

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases