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

This study is currently recruiting participants.
Verified November 2017 by Evalve
Sponsor:
ClinicalTrials.gov Identifier:
NCT03227757
First Posted: July 24, 2017
Last Update Posted: November 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
Evalve
  Purpose
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 Intervention
Tricuspid Valve Insufficiency Device: Tricuspid Valve Repair System

Study Type: Interventional
Study Design: 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)

Further study details as provided by Evalve:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: August 2023
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

This is a prospective, single arm, multi-center study.

A minimum of 75 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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be 18 years or older at time of consent and must not be a member of a vulnerable population.
  2. Subject or a legally authorized representative 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

    a. Conditional - NYHA II will be allowed in subjects with severe or greater TR

  6. No indication for left-sided or pulmonary valve correction.
  7. The Local Heart Team concur that percutaneous transcatheter intervention is appropriate for the subject.

    Echocardiographic Inclusion Criteria:

  8. 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). The ECL will also confirm the tricuspid valve anatomy to be suitable for implantation. 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.
  9. Subjects with tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team
  10. 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 30 days prior 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 to dual antiplatelet and anticoagulant therapy.
  17. Subjects with life expectancy of less than 12 months due to non-cardiac conditions

    Echocardiographic Exclusion Criteria:

  18. Subjects with tricuspid stenosis
  19. Subjects with tricuspid valve calcification
  Contacts and Locations
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: Karine Miquel 2-71-41671 ext +32 karine.miquel@av.abbott.com
Contact: Nadia Bouhdi nadia.bouhdi@av.abbott.com

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

Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT03227757     History of Changes
Other Study ID Numbers: 16-517
First Submitted: June 20, 2017
First Posted: July 24, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017
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