Surgical Treatment of Ischemic Mitral Regurgitation

The Effect of Different Surgical Methods in the Treatment of Patients With Ischemic Mitral Regurgitation and Assess the Dynamics of Heart Failure and the Effectiveness of Surgical Treatment of Mitral Valve.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01368575

Acronym

TIME

Enrollment

420

Registered

2011-06-08

Start date

2011-05-31

Completion date

2015-11-30

Last updated

2015-09-23

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

Conditions

Mitral Valve Insufficiency

Keywords

Ischemic, Mitral, Valve, Insufficiency, SVR

Brief summary

The primary objective is to estimate surgical treatment (prosthesis or plastic) of moderate and severe ischemic mitral regurgitation combined with CABG in patients with CAD and impact on heart failure and progress of mitral regurgitation.

Interventions

PROCEDURECABG

CABG

PROCEDURECABG combined with MV repair with remodeling annuloplasty rigid ring

CABG combined with MV repair with remodeling annuloplasty rigid ring

PROCEDURECABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus

CABG combined with MV repair with remodeling annuloplasty

PROCEDURECABG and MV replacement

coronary artery bypass grafting and mitral valve replacement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent. * Patients with a verified diagnosis of CAD, including post myocardial infarction scar. * Coronary artery pathology to be coronary artery bypasses grafting. * The presence of moderate or severe ischemic mitral regurgitation.

Exclusion criteria

* The patient did not sign the informed consent. * Aortic valve disease requiring prosthetic or aortic valve repair. * Organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve). а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve * Patients with acute coronary syndrome. * The presence of the indications for angioplasty of the coronary arteries. * Coronary artery bypasses grafting in history. * Parallel patient participation in other studies. * The organs diseases, which can be reason to death after surgery during the first 3 years.

Design outcomes

Primary

Measure	Time frame
Assess the degree of mitral regurgitation in the early and late term of the study. Identify the cause of the return of IMR. Determine the dynamics of heart failure in patients with IMR.	3,6,12,24,36 months

Secondary

Measure	Time frame
Assessment of IMR	3 years

Countries

Russia

Contacts

Primary ContactAlexander Cherniavskiy, MD, Prof.

amchern@mail.ru+7 383 3322655

Backup ContactVidadi Efendiev, MD

vidadiue@gmail.com+7 383 3322655

Outcome results

None listed

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