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Myocardial Protection in Minimally Invasive Mitral Valve Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04231903
Enrollment
116
Registered
2020-01-18
Start date
2014-06-01
Completion date
2018-12-31
Last updated
2020-01-18

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

Conditions

Minimally Invasive Surgery, Mitral Valve Prolapse, Myocardial Protection

Brief summary

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.

Interventions

DEVICEAortic clamp

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

Sponsors

University of Turin, Italy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
cTn-T levels immediately after surgeryImmediately after surgeryMyocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels immediately after surgeryImmediately after the surgeryMyocardial 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
cTn-T levels 6hhour 6 after surgeryMyocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 6hhour 6 after surgeryMyocardial 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
cTn-T levels 12hhour 12 after surgeryMyocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 12hhour 12 after surgery(CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping
cTn-T levels 24hhour 24 after surgeryMyocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping
CK-MB levels 24hhour 24 after surgeryMyocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping

Outcome results

None listed

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