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NCT Number: NCT01641614

Beating Versus Arrested Heart for Mitral Valve Replacement

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.

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Key information

Conditions

Mitral Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Insufficiency Mitral Valve Insufficiency Mitral Valve Stenosis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Ana Neri

Salvador, Estado de Bahia, 40.000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mitral valve replacement

Procedure

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

Primary outcomes

  1. mitral valve replacement

    Time frame: 1hour , 3 hours and 1 hour after surgery procedure

    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 with the beating heart also in the group B.

Secondary outcomes

  1. Ultramicroscopic evidences of ischemia

    Time frame: 1hour, 3 hours and 1 hour after aortic clamping

    During the surgery myocardial biopsies were performed as full thickness transmural specimen of three small fragments for electromicrospic analysis

Sponsors and collaborators

Lead sponsor

Federal University of Bahia

Other

Registry information

Official study title

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

Acronym: BAHMVR

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 17, 2012
Registry last updated
Jul 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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