Clinical Trials Directory

Trials / Completed

CompletedNCT04231903

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
Phase
Study type
Observational
Enrollment
116 (actual)
Sponsor
University of Turin, Italy · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEAortic clampIn the firs group an endo-aortic clamp is used and in the second group an external clamp is used.

Timeline

Start date
2014-06-01
Primary completion
2018-06-30
Completion
2018-12-31
First posted
2020-01-18
Last updated
2020-01-18

Source: ClinicalTrials.gov record NCT04231903. Inclusion in this directory is not an endorsement.