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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01641614
Acronym
BAHMVR
Enrollment
34
Registered
2012-07-17
Start date
2010-04-30
Completion date
2012-01-31
Last updated
2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Insufficiency, Mitral Stenosis

Keywords

Mitral valve, valve replacement, arrested heart, beating heart

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.

Interventions

PROCEDUREMitral valve replacement

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

PROCEDUREmitral valve replacement

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

Sponsors

Federal University of Bahia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
mitral valve replacement1hour , 3 hours and 1 hour after surgery procedureMitral 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

MeasureTime frameDescription
Ultramicroscopic evidences of ischemia1hour, 3 hours and 1 hour after aortic clampingDuring the surgery myocardial biopsies were performed as full thickness transmural specimen of three small fragments for electromicrospic analysis

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026