Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University
About this trial
The purpose of this study is to evaluate the outcomes of complete (preservation of both anterior and posterior leaflets) versus partial (preservation of posterior leaflet only) preservation of subvalvular apparatus in cases of mitral valve replacement
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Age between 18 and 60 years
Rheumatic mitral disease indicated for mitral valve replacement
Concomitant other valve disease
Disqualifiers
- Patients who have undergone previous mitral valve surgery or other heart surgery.
Patients with ischemic mitral disease.
emergency operation.
patients with significant comorbidities (severe pulmonary disease or end stage renal disease).
Trial design
Design model
Parallel
Treatments tested in this trial
mitral valve replacement
Procedure/Surgerycomplete versus partial preservation of subvavular apparatus during mitral valve replacement
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: complete (preservation of both anterior and posterior leaflets) preservation of subvalvular apparatuActive comparator 1 intervention
Group B: partial (preservation of posterior leaflet only) preservation of subvalvular apparatusActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement regarding: * Postoperative morbidity and mortality * LV function and the change of cardiac chamber dimensions.
Time frame
anticepated 3 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: