Band Versus Ring for Tricuspid Regurgitation

Flexible Band Versus Rigid Ring Annuloplasty for the Correction of Tricuspid

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Procedure: Tricuspid Annuloplasty

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Ring; Patients in Group Ring will undergo tricuspid rigid ring annuloplasty	Procedure: Tricuspid Annuloplasty; Patients will undergo repair of tricuspid regurgitation
Active Comparator: Group Band; Patients in Group Band will undergo flexible band annuloplasty	Procedure: Tricuspid Annuloplasty; Patients will undergo repair of tricuspid regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	at follow-up of 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: Affiliated Hospital of Nantong University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: JPH2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No