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TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System (TRI-REPAIR)

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ClinicalTrials.gov Identifier: NCT02981953
Recruitment Status : Active, not recruiting
First Posted : December 5, 2016
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:

The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis .However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.

The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September 2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty, however deployed on the beating heart through a transvenous approach. The CE mark study with 30 subjects has been completed and documented significant reduction of severity of MR and improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ), Ney York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system for repair the Tricuspid Regurgitation.


Condition or disease Intervention/treatment Phase
Tricuspid Valve Insufficiency Tricuspid Regurgitation Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Valve Diseases Heart Diseases Cardiac Valve Annuloplasty Device: Cardioband Tricuspid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
Study Start Date : October 2016
Actual Primary Completion Date : January 1, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Cardioband Tricuspid procedure
Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
Device: Cardioband Tricuspid
The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.




Primary Outcome Measures :
  1. Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE) [ Time Frame: 30 days ]
  2. Successful access, deployment and positioning of the Cardioband device [ Time Frame: Intra-procedure ]
  3. Change in septolateral dimension [ Time Frame: 30 days ]
  4. Septolateral diametion reduction [ Time Frame: intra procedure ]

Secondary Outcome Measures :
  1. Change in TR grade, Effective regurgitant orifice area (EROA) and Regurgitant Volume (by Echocardigraphy) [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  2. Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  3. Technical success [ Time Frame: 6 months ]
  4. Technical success [ Time Frame: 12 months ]
  5. Change in NYHA classification [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  6. Change in 6-Minute Walk Distance [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  7. Change in MLWHF Quality of Life Questionnaire [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  8. Change in left ventricle ejection fraction (LVEF) [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  9. Change in left ventricle end diastolic volume index (LVEDVI) [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  10. Change in left ventricle end syastolic volume index (LVESVI) [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  11. Change in N-terminal prohormone of brain natriuretic peptide (NT-pro BNP) [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  12. Change in Diuretic Therapy [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  13. Change in glutamic oxaloacetic transaminase (GOT), Gamma-glutamyl transferase (GGT) and Bilirubin [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  14. Change in blood urea nitrogen (BUN) Creatinine clearance [ Time Frame: 1, 6, 12, and 24 months over baseline ]
  15. Change in activity by wearable device [ Time Frame: 1, 6, 12, and 24 months over baseline ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg
  2. ≥18 years old
  3. New York Heart Association (NYHA) Class II-IVa
  4. Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
  5. LVEF ≥ 30%
  6. Patient is willing and able to comply with all specified study evaluations
  7. The Local Site Heart Team concur that surgery will not be offered as a treatment option
  8. Transfemoral access of the Cardioband is determined to be feasible

Exclusion Criteria:

  1. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
  2. Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
  3. Previous tricuspid valve repair or replacement
  4. Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography
  5. Active endocarditis
  6. MI or known unstable angina within the 30 days prior to the index procedure
  7. Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index
  8. Hemodynamic instability or on IV inotropes
  9. Cerebrovascular Accident (CVA) within the past 6 months
  10. Subject is on chronic dialysis
  11. Anemia (Hb < 9 g/L) not corrected by transfusion
  12. Bleeding disorders or hypercoaguable state
  13. Active peptic ulcer or active gastrointestinal (GI) bleeding
  14. Contraindication to anticoagulants
  15. Known allergy to stainless steel, nickel, and/or polyester
  16. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
  17. In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
  18. Life expectancy of less than 12 months
  19. Impaired judgment and/or is undergoing emergency treatment
  20. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
  21. intra-cardiac masses, thrombi or vegetations
  22. Patients with cardiac cachexia
  23. Subjects in whom transesophageal echocardiography is contraindicated
  24. . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
  25. Untreated clinically significant CAD requiring revascularization
  26. Echocardiographic evidence of severe right ventricular dysfunction
  27. Any coronary or endovascular surgery, within 3 months prior to procedure

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): NCT02981953


Locations
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France
Bichat hospital
Paris, France, 18 75877
Germany
Bonn University
Bonn, Germany
Asklepios Klinik, St. Georg
Hamburg, Germany, 5 20099
Medizinisches Versorgungszentrum, Hamburg
Hamburg, Germany, D-22527
Koln, Universitätsklinikum
Koln, Germany
Universitatsmedizin Mainz
Mainz, Germany
München, LMU Klinikum der Universität München
Munich, Germany
Italy
Hospital san raffaele
Milano, Italy, 20132
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Georg Nickenig, MD University Hospital, Bonn

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02981953     History of Changes
Other Study ID Numbers: TR1-1
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edwards Lifesciences:
Valtech Cardio
Cardioband
Tricuspid

Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Vomiting
Heart Valve Diseases
Tricuspid Valve Insufficiency
Signs and Symptoms, Digestive
Signs and Symptoms