Myocardial Protection in Minimally Invasive Mitral Valve Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-01

Study Completion Date

2018-12-31

Brief Summary

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Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been re-ported. However, some concerns have emerged about the adequacy of myocardial protection dur-ing the minimally invasive approach and about the role of aortic clamping strategies in this contest.

Aim of this study was to compare the efficacy, in terms of myocardial protection, of the en-do-aortic clamp (EAC) versus the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV repair.

A single center, prospective observational study was performed between June 2014 to June 2018 on patients undergoing right mini-thoracotomy MV repair with retrograde arterial perfusion and EAC or TTC. The selection of one setting in respect to the other was patient orientated. Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) and cardiac Troponin T (cTn-T) blood levels immediately after the surgical procedure and at 6, 12, and 24 hours and compared between the two groups.

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Detailed Description

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Conditions

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Myocardial Protection Minimally Invasive Surgery Mitral Valve Prolapse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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EAC

Patients undergoing surgery endo-aortic clamp.

Aortic clamp

Intervention Type DEVICE

In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.

TTC

Patients undergoing surgery through trans-thoracic aortic clamp.

Aortic clamp

Intervention Type DEVICE

In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.

Interventions

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Aortic clamp

In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Surgical indication for mitral valve repair.
* Right mini-thoracotomy approach.
* Retrograde arterial perfusion.

Exclusion Criteria

* Age more than 75 years.
* Cardiac ejection fraction lower than 40%.
* Previous cardiac surgery procedures for coronary artery bypass graft.
* Any degree of coronary artery disease.
* Severe peripheral vascular disease.
* Concomitant procedures for atrial fibrillation ablation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No