NCT04078867

Brief Summary

This study includes 105 patients who underwent repair for ≥ moderate tricuspid regurgitation (TR) during mitral valve replacement for rheumatic valve disease. Between January 2016 and December 2018, a group of 23 patients underwent ring annuloplasty with Edward MC3 rings were compared to another group of 82 patients underwent standard suture (DeVega) repair. The primary outcome was residual TR (≥ moderate TR).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

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 Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

August 31, 2019

Last Update Submit

September 4, 2019

Conditions

Functional Tricuspid Regurgitation

Keywords

Tricuspid valveFunctional tricuspid regurgitationSuture annuloplastyRing annuloplasty

Outcome Measures

Primary Outcomes (1)

  • Residual tricuspid regirgitation (TR)

    residual TR is defined when there is moderate or above degree of TR at the last follow-up echocardiography of the patient

    3-33 months

Study Arms (2)

DeVega

The DeVega repair is performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension

Procedure: tricuspid valve repair

MC3 ring

MC3 ring annuloplasty is performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension

Procedure: tricuspid valve repair

Interventions

tricuspid valve repairPROCEDURE

Tricuspid valve repair during mitral valve replacement for rheumatic heart disease using suture (DeVega) repair or ring annuloplasty

DeVegaMC3 ring

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent repair for functional tricuspid regurgitation during mitral valve replacement for rheumatic valve disease

You may qualify if:

  • Rheumatic mitral valve disease
  • Surgery for mitral valve replacement
  • Severe functional tricuspid regurgitation
  • Moderate functional tricuspid regurgitation with annular dilatation \> 40 mm
  • Moderate functional tricuspid regurgitation with preoperative systolic pulmonary artery pressure (SPAP) \>50 mmHg

You may not qualify if:

  • Patients with non-rheumatic mitral disease
  • Combined mitral and aortic valve replacement
  • Mitral valve repair
  • Concomitant coronary artery or aortic surgery
  • Mild or organic tricuspid regurgitation
  • Emergency surgery
  • Reoperations
  • Invalid or missed data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yasser A Kamal, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 6, 2019

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09