NCT04093297

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jan 2025Dec 2028

First Submitted

Initial submission to the registry

September 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
5.3 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

September 16, 2019

Last Update Submit

April 14, 2026

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mortality

    up to 3 months of intervention

Study Arms (2)

Group Ring

ACTIVE COMPARATOR

Patients in Group Ring will undergo tricuspid rigid ring annuloplasty

Procedure: Tricuspid Annuloplasty

Group Band

ACTIVE COMPARATOR

Patients in Group Band will undergo flexible band annuloplasty

Procedure: Tricuspid Annuloplasty

Interventions

Tricuspid AnnuloplastyPROCEDURE

Patients will undergo repair of tricuspid regurgitation

Group BandGroup Ring

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Subject must be 18 years and 70 years at time of consent and must not be a member of a vulnerable population.
  • \. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
  • \. Subjects with tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).

You may not qualify if:

  • \. Patient unable or unwilling to provide informed consent;
  • \. Subjects with mild tricuspid regurgitation;
  • \. Emergency surgery;
  • \. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure;
  • \. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment;
  • \. 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;
  • \. Subjects with permanent or temporary pacemaker implantation;
  • \. Subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator;
  • \. History of mitral/tricuspid endocarditis within the last 12 months;
  • \. Subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated;
  • \. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding);
  • \. Female patient is pregnant (urine HCG test result positive) or lactating;
  • \. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
  • \. Subjects with left ventricular ejection fraction (LVEF)≤20%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (1)

  • 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: 31287501BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff of Department of Cardiothoracic Surgery

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 18, 2019

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

CN(1)