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Myocardial Protection in Minimally Invasive Mitral Valve Surgery

U

University of Turin

Status

Completed

Conditions

Myocardial Protection
Minimally Invasive Surgery
Mitral Valve Prolapse

Treatments

Device: Aortic clamp

Study type

Observational

Funder types

Other

Identifiers

NCT04231903
0063123

Details and patient eligibility

About

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.

Enrollment

116 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

116 participants in 2 patient groups

EAC
Description:
Patients undergoing surgery endo-aortic clamp.
Treatment:
Device: Aortic clamp
TTC
Description:
Patients undergoing surgery through trans-thoracic aortic clamp.
Treatment:
Device: Aortic clamp

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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