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Functional Tricuspid RegurgitationNCT04078867

Outcome of MC3 Ring Annuloplasty for Functional Tricuspid Regurgitation

An observational study of Functional Tricuspid Regurgitation, run by Minia University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Functional Tricuspid Regurgitation
What is being tested?
tricuspid valve repair
Type of treatment
Surgery or procedure
How many people
105 participants
Where
No sites listed yet
Study dates
1 Jan 2016to 31 Dec 2018
How long will I take part?
3 Months
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Outcome of MC3 Ring Annuloplasty for Moderate and Severe Functional Tricuspid Regurgitation Associated With Rheumatic Mitral Valve Disease

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).

Read the detailed description

This study evaluated early and midterm outcomes after operations for TV repair which were performed at our institution, between January 2016 and December 2018. The mean follow-up duration was 18.84±9.90 months (range: 3-33 months). The study included 105 patients who underwent repair for FTR during mitral valve replacement for rheumatic valve disease. There were 82 patients underwent suture (DeVega) repair and 23 patients underwent ring annuloplasty using Edward MC3 incomplete 3D ring. The indications of surgery for FTR were: (1) severe TR; or (2) moderate TR with annular dilatation greater than 40 mm and/or preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg. We excluded 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 or missed data. Based on echocardiographic data, the severity of TR was graded as: 0 (no TR), 1+ (mild TR), 2+ (mild to moderate TR), 3+ (moderately severe TR), or 4+ (severe).

The type of tricuspid valve repair was chosen in according to surgeon's preference and echocardiographic criteria of TV. The DeVega repair was performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension, while ring annuloplasty was performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension. The DeVega repair was performed on a beating heart using pledget-supported two 4-0 polypropylene running parallel sutures. The MC3 ring annuloplasty was performed through right atriotomy using cardiopulmonary bypass and cardioplegic arrest. The ring size was determined after measurement of the length of the attachments of the tricuspid septal leaflet (the distance between the anteroseptal and septoposterior commissures) or the surface area of the anterior leaflet. The chosen ring was undersized by at least one size. The ring was implanted from the anteroseptal commissure to the middle of the septal leaflet. A series of 8 to10 mattress sutures with a 2-0 Ethibond multifilament suture were made on the tricuspid annulus starting from the center of the septal annulus to the anteroseptal commissure in the counter-clockwise direction, to avoid the atrioventricular conduction tissue. Thereafter, the sutures were placed through the sewing ring of the prosthesis , followed by lowering and securing of the ring to the annulus The collected pre-operative data included age, sex, New York Heart Association (NYHA) functional class, , and the type of preoperative mitral valve disease. The primarily assessed post-operative outcome was residual TR (≥ moderate TR; ≥ grade +2). Other assessed pre- and post-operative parameters included NYHA functional class, and echocardiographic data regarding grade of TR, SPAP, tricuspid annulus (TA) diameter, tricuspid annular plane systolic excursion (TAPSE), left atrial diameter (LAD), left ventricular end-diastolic dimension (LVEDD), left ventricular end-systolic dimension (LVESD), and left ventricular ejection fraction (LVEF).

Being tested
tricuspid valve repair
Keywords
Tricuspid valve, Functional tricuspid regurgitation, Suture annuloplasty, Ring annuloplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tricuspid valve repairProcedure or surgery

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

Study groups in NCT04078867
Study groupRoleWhat they receive
DeVegaThe DeVega repair is performed when the patient had minimal annular dilation and lower severity of pulmonary hypertension
Receives: Procedure: tricuspid valve repair
MC3 ringMC3 ring annuloplasty is performed in patients with severe tricuspid annular dilation and severe pulmonary hypertension
Receives: Procedure: tricuspid valve repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3-33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start1 Jan 2016
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
105 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04078867
Sponsor's protocol ID
62-15
Status last verified
Sep 2019
First submitted
31 Aug 2019
Last updated
6 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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