Band Versus Ring for Tricuspid Regurgitation

Overview

Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. This study aims to prospectively compare the efficacy and long term outcomes of flexible band versus rigid ring annuloplasty for the correction of tricuspid regurgitation.

Full Title of Study: “Flexible Band Versus Rigid Ring Annuloplasty for the Correction of Tricuspid”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2021

Interventions

  • Procedure: Tricuspid Annuloplasty
    • Patients will undergo repair of tricuspid regurgitation

Arms, Groups and Cohorts

  • Active Comparator: Group Ring
    • Patients in Group Ring will undergo tricuspid rigid ring annuloplasty
  • Active Comparator: Group Band
    • Patients in Group Band will undergo flexible band annuloplasty

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in severity of tricuspid regurgitation
    • Time Frame: within 3 months
    • Improvement in tricuspid regurgitation: refers to Mild or No tricuspid regurgitation Tricuspid regurgitation is graded as mild, moderate, and severe based on regurgitant jet area

Secondary Measures

  • Mortality
    • Time Frame: up to 3 months of intervention
    • Mortality: Mortality within hospital stay or 1 month postoperative.

Participating in This Clinical Trial

Inclusion Criteria

  • 1. Subject must be 18 years and 80 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. Subjects with moderate or greater tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
  • 4. Subjects with moderate tricuspid regurgitation will only be included in the trial if moderate tricuspid regurgitation is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by echocardiography.
  • 5. Isolated functional symptomatic tricuspid regurgitation of moderate to severe or greater, with annular dilatation of ≥ 40mm;
  • 6. Requirement for concomitant left heart valve surgery;
  • 7. Requirement for concomitant coronary artery surgery;
  • 8. Requirement for concomitant atrial fibrillation surgery;
  • 9. Available and able to return to the study site for post-procedural follow-up examination;

Exclusion Criteria

  • 1. Patient unable or unwilling to provide informed consent;
  • 2. Subjects with mild tricuspid regurgitation;
  • 3. Emergency surgery;
  • 4. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure;
  • 5. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment;
  • 6. Subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year;
  • 7. Subjects with permanent or temporary pacemaker implantation;
  • 8. Subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator;
  • 9. History of mitral/tricuspid endocarditis within the last 12 months;
  • 10. Subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated;
  • 11. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding);
  • 12. Female patient is pregnant (urine HCG test result positive) or lactating;
  • 13. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
  • 14. Subjects with left ventricular ejection fraction (LVEF)≤20%.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hong Liu, Staff of Department of Cardiothoracic Surgery – The First Affiliated Hospital with Nanjing Medical University
  • Overall Contact(s)
    • Yong-feng Shao, MD, 025-83714511, yongfengshao30@hotmail.com

References

Veen KM, Etnel JRG, Quanjel TJM, Mokhles MM, Huygens SA, Rasheed M, Oei FBS, Ten Cate FJ, Bogers AJJC, Takkenberg JJM. Outcomes after surgery for functional tricuspid regurgitation: a systematic review and meta-analysis. Eur Heart J Qual Care Clin Outcomes. 2020 Jan 1;6(1):10-18. doi: 10.1093/ehjqcco/qcz032.

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