Clinical trial NCT01641614: Beating Versus Arrested Heart for Mitral Valve Replacement
Official title: Clinical and Ultramicroscopic Myocardial Randomized Study of On-Pump Beating Heart Mitral Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mitral Stenosis
Mitral Insufficiency
Keywords: Mitral valve
valve replacement
arrested heart
beating heart
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: During open-heart surgery prevention of ischemia and reperfusion following cardioplegic arrest are essential for myocardial protection. Beating heart surgery on normothermic bypass simulates physiologic cardiac status and is good method for myocardial protection. A comparison of both available techniques for valve replacement arrested heart versus on-pump empty beating heart of the clinical and ultramicroscopic myocardial alterations will allowed to better understand myocardial protection because eliminated the use of cardioplegia and the corollary risk of ischemic reperfusion injury.

Eligibility criteria: Inclusion Criteria:

* all patient included into the study were adults 18-60 years old,
* with an echocardiography diagnosis of mitral and/or tricuspid valve disease due to inflammatory acquired diseases,
* no previous history of cardiac surgery and d) elective indication for valve replacement.

Exclusion Criteria:

* with metabolic diseases such as diabetes mellitus and uremia,
* with coronary artery diseases,
* dilated myocardiopathy,
* with severe chronic pulmonary obstructive diseases,
* with present or past history of malignant diseases,
* acute endocarditis
* with severe pre-operatory laboratory parameters such as creatinine levels \> 3mg/dL, Hemoglobin ≤ 7.0 g/dL, Prothrombin time/activity ≤ 70% and clotting time ≥ 10 minutes.

Primary outcomes:
measure: mitral valve replacement
timeFrame: 1hour , 3 hours and 1 hour after surgery procedure
Secondary outcomes:
measure: Ultramicroscopic evidences of ischemia
timeFrame: 1hour, 3 hours and 1 hour after aortic clamping
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Hospital Ana Neri
state: Bahia
Study officials:
References:
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