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Completed

NCT Number: NCT04231903

Myocardial Protection in Minimally Invasive Mitral Valve Surgery

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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Key information

Conditions

Myocardial Protection Cardiovascular Diseases Heart Diseases Heart Valve Diseases Heart Valve Prolapse Minimally Invasive Surgery Mitral Valve Prolapse

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Aortic clamp

Device

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

Primary outcomes

  1. cTn-T levels immediately after surgery

    Time frame: Immediately after surgery

    Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping

  2. CK-MB levels immediately after surgery

    Time frame: Immediately after the surgery

    Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping

  3. cTn-T levels 6h

    Time frame: hour 6 after surgery

    Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping

  4. CK-MB levels 6h

    Time frame: hour 6 after surgery

    Myocardial protection was assessed through creatinine kinase-myocardial band (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping

  5. cTn-T levels 12h

    Time frame: hour 12 after surgery

    Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping

  6. CK-MB levels 12h

    Time frame: hour 12 after surgery

    (CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping

  7. cTn-T levels 24h

    Time frame: hour 24 after surgery

    Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping

  8. CK-MB levels 24h

    Time frame: hour 24 after surgery

    Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Endo-aortic Versus Trans-thoracic Clamping in Right Mini-thoracotomy Mitral Valve Repair: Outcome on Myocardial Pro-tection

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2020
Registry last updated
Jan 18, 2020

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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