Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03604484

Enrollment

106

Registered

2018-07-27

Start date

2009-05-01

Completion date

2017-01-01

Last updated

2018-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Valve Insufficiency

Brief summary

Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.

Detailed description

The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures. A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta \>3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.

Interventions

PROCEDURETricuspid annuloplasty

Tricuspid annuloplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* patients undergoing mitral valve surgery with less than sever tricuspid insufficiency

Exclusion criteria

* presence of pacemaker lead through the tricuspid valve * acute endocarditis * minimally invasive approach * Functional mitral valve insufficiency

Design outcomes

Primary

Measure	Time frame
Incidence of more than mild tricuspid insufficiency	5 year

Secondary

Measure	Time frame	Description
VO2 max	1 year	Physical function capacity measured by VO2 max
Right ventricular function	5 year	Right ventricle function at the follow up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026