Band Versus Ring for Tricuspid Regurgitation

Official title

Flexible Band Versus Rigid Ring Annuloplasty for the Correction of Tricuspid

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.

Interventions

• Procedure Tricuspid Annuloplasty
  Patients will undergo repair of tricuspid regurgitation

Primary outcome measures

• A composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death. [Time frame: at follow-up of 5 years]

Secondary outcome measures (1)

• Mortality [Time frame: up to 3 months of intervention]

Eligibility criteria

Inclusion criteria

• 1\. Subject must be 18 years and 70 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 tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).

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%.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Nanjing Medical University — Nanjing

Publications

• 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. PMID 31287501

Identifiers

NCT: NCT04093297 · JPH2019

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗