Outcome of Preserved Mitral Valve Apparatus During Mitral Valve Replacement (EarlyOutcome)

S

Suez Canal University

Status

Completed

Conditions

Mitral Valve Replacement
Abnormality of Mitral Valve Annulus (Disorder)
Diseases of Mitral Valves

Treatments

Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets

Study type

Interventional

Funder types

Other

Identifiers

NCT05438433
2796#

Details and patient eligibility

About

Are there differences in outcome of mitral valve replacement with preservation of mitral apparatus among rheumatic and/or ischemic mitral lesions?. Mitral valve replacement with preservation of leaflets, and added coronary artery-bypass surgery, when indicated, is it a feasible and reproducible procedure?. The study was designed to compare outcome after prosthetic mitral replacement with preservation of mitral apparatus for rheumatic valve disease with outcome of replacement for ischemic myocardium and mitral valve disease, The outcomes will be guided by clinical assessment. and echo-cardiograph.

Full description

Objectives: The aim is to compare outcome of modified preservation of mitral valve apparatus during prosthetic mitral replacement for rheumatic versus myocardial ischemia &mitral valve disease. Methods ;This prospective cross-sectional comparative study will include 50 patients with isolated rheumatic mitral valve disease (group A) and 50 patients with mitral disease and myocardial ischemia (group B), surgery is expected to be performed between 2017 and 2020 at one center. All patients will have modified preservation of mitral apparatus during prosthetic mitral replacement. Additionally, group B patients will have bypass grafts to left anterior descending and/or posterior descending / right coronary artery. Data will be collected and analyzed. The Institutional Review Board (IRB), Ethics Committee (EC)-approval and consent of each patient were obtained. Criteria for inclusion of patients and exclusion of others were determined according to the guide lines. Statistical analysis:: Qualitative variables and their association among both groups were studied by applying Chi-square test and Fisher Exact test. Quantitative variables among both groups were compared by applying independent samples t-test. P < 0.05 values mean statistically-significant results.

Enrollment

100 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria::

Mitral stenosis (MS)

symptoms are severely limiting and cannot be managed with diuresis and heart rate control.

Mitral regurgitation(MR):

* acute severe MR require surgical correction for hemo-dynamics and relief of symptoms .

Chronic primary mitral regurgitation:

* rheumatic heart disease: replacement before irreversible changes occur can be curative.

Mixed Mitral Stenosis and Mitral Regurgitation:

  • If beta blockers and diuretics do not relieve symptoms, replacement should be performed only in patients who have severe limiting symptoms.
  • Myocardial ischemia associating or complicated with miral valve disease.

Exclusion criteria

Patients showing good response to medical therapy, and Cases complicated by:

  • ineffective endocarditis,
  • previous myocardial re-vascularization
  • ischemic ventricular septal defect,
  • left ventricular aneurysm,
  • Ruptured papillary muscles of mitral apparatus.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Group A
Sham Comparator group
Description:
50 patients with isolated rheumatic mitral valve disease (group A)
Treatment:
Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets
Group B
Other group
Description:
50 patients with mitral disease and myocardial ischemia (group B)
Treatment:
Device: St.Jude bi leaflet prosthetic mitral valve to replace the diseased valve with preservation of both leaflets

Trial documents
1

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems