Skip to main content
OpenTrials
Completed

NCT Number: NCT02981953

TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tricuspid Valve Insufficiency Cardiac Valve Annuloplasty Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Regurgitation Tricuspid Valve Regurgitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Bichat-Claude Bernard, Paris, France

Loading trial locations.

About this study

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), New 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
  • Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
  • Previous tricuspid valve repair or replacement
  • Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography
  • Active endocarditis
  • MI or known unstable angina within the 30 days prior to the index procedure
  • Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index
  • Hemodynamic instability or on IV inotropes
  • Cerebrovascular Accident (CVA) within the past 6 months
  • Subject is on chronic dialysis
  • Anemia (Hb < 9 g/dL) not corrected by transfusion
  • Bleeding disorders or hypercoaguable state
  • Active peptic ulcer or active gastrointestinal (GI) bleeding
  • Contraindication to anticoagulants
  • Known allergy to stainless steel, nickel, and/or polyester
  • Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
  • 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
  • Life expectancy of less than 12 months
  • Impaired judgment and/or is undergoing emergency treatment
  • 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
  • intra-cardiac masses, thrombi or vegetations
  • Patients with cardiac cachexia
  • Subjects in whom transesophageal echocardiography is contraindicated
  • . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
  • Untreated clinically significant CAD requiring revascularization
  • Echocardiographic evidence of severe right ventricular dysfunction
  • Any coronary or endovascular surgery, within 3 months prior to procedure

Treatment and study plan

Cardioband Tricuspid

Device

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 outcomes

  1. Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)

    Time frame: 30 days

    Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE)

  2. Access, Deployment and Positioning of the Cardioband Device

    Time frame: Intra-procedure

    Successful access, deployment and positioning of the Cardioband device

Secondary outcomes

  1. Technical Success

    Time frame: 1, 6, 12, and 24 months

    Successful access, deployment and positioning of the Cardioband device and septolateral reduction.

  2. Tricuspid Regurgitation [Paired Baseline and Follow-Up]

    Time frame: 1, 6, 12, and 24 months over baseline

    Data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, and Severe. Data analysis per core lab.

  3. Tricuspid Regurgitation [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, Severe. Data analysis per core lab.

  4. Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]

    Time frame: 1, 6, 12, and 24 months over baseline

    Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab

  5. Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All data available for Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.

  6. Regurgitant Volume [Paired Baseline and Follow-Up]

    Time frame: 1, 6, 12, and 24 months over baseline

    Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.

  7. Regurgitant Volume [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.

  8. TAPSE [Paired Baseline and Follow-Up]

    Time frame: 1, 6, 12, and 24 months over baseline

    Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.

  9. TAPSE [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All data for Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analyses based on core lab assessment.

  10. NYHA [Paired Baseline and Follow-Up]

    Time frame: 1, 6, 12, and 24 months over baseline

    NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline.

    Measure Description: NYHA Classification - The stages of heart failure:

    • Class I - No symptoms and no limitation in ordinary physical activity
    • Class II - Mild symptoms and slight limitation during ordinary activity.
    • Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
    • Class IV - Severe limitations. Experiences symptoms even while at rest.

  11. NYHA [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All data available for NYHA classification at 1 month, 6 months, 12 months, and 24 months over baseline.

    Measure Description: NYHA Classification - The stages of heart failure:

    • Class I - No symptoms and no limitation in ordinary physical activity
    • Class II - Mild symptoms and slight limitation during ordinary activity.
    • Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.
    • Class IV - Severe limitations. Experiences symptoms even while at rest.

  12. 6MWT [Paired Baseline and Follow-Up]

    Time frame: 1, 6, 12, and 24 months over baseline

    Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.

  13. 6MWT [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.

  14. Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]

    Time frame: 1, 6, 12, and 24 months over baseline

    The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.

  15. Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.

  16. Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]

    Time frame: 1, 6, 12, and 24 months over baseline

    Left ventricle ejection fraction data available for 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis based on core lab assessment.

  17. Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All available data for left ventricle ejection fraction at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per echo core lab.

  18. Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline.

  19. Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline.

  20. NT-pro BNP [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline.

  21. Diuretic Therapy

    Time frame: 1, 6, 12, and 24 months over baseline

    Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline.

  22. Bilirubin [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline.

  23. Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline.

  24. Activity by Wearable Device

    Time frame: 1, 6, 12, and 24 months over baseline

    Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline.

  25. Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline.

  26. Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]

    Time frame: 1, 6, 12, and 24 months over baseline

    All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Acronym: TRI-REPAIR

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 5, 2016
Registry last updated
Jun 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.