CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Mitral valve replacement +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01641614
NCT01641614Phase 4Completed
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Clinical and Ultramicroscopic Myocardial Randomized Study of On-Pump Beating Heart Mitral Valve Replacement

Federal University of Bahia·interventional·Posted Jul 17, 2012·Updated Jul 18, 2012

In Brief

A Phase 4 clinical trial evaluating Mitral valve replacement and mitral valve replacement for Mitral Stenosis and Mitral Insufficiency. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the immediately clinic and ultramicroscopic myocardial cellular ischemia and reperfusion to replace of the mitral valve using arrested heart versus on-pump empty beating heart surgical techniques.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Stenosis, Mitral Insufficiency
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2012
Enrollment StartApr 1, 2010
Primary CompletionMar 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.0 years ago

Interventions

Mitral valve replacementprocedure

Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups

mitral valve replacementprocedure

Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups