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Beating Versus Arrested Heart for Mitral Valve Replacement

Clinical and Ultramicroscopic Myocardial Randomized Study of On-Pump Beating Heart Mitral Valve Replacement

NCT01641614•Federal University of Bahia

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

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hospital Ana Neri

Salvador, Estado de Bahia, Brazil

Key Dates

Start Date

April 1, 2010

Primary Completion Date

March 1, 2011

Completion Date

January 1, 2012

Last Updated

July 18, 2012

Enrollment

ACTUAL participants

Conditions

Mitral StenosisMitral Insufficiency

Interventions

Mitral valve replacement

PROCEDURE

mitral valve replacement

PROCEDURE

AltaValve Pivotal Trial

NCT06465745

Mitral RegurgitationMitral Insufficiency+3 more

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RECRUITING

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

NCT06911099

Atrial Functional Mitral RegurgitationMitral Insufficiency

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Beating Versus Arrested Heart for Mitral Valve Replacement

Inclusion Criteria

Exclusion Criteria

AltaValve Pivotal Trial

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

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