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
| Type | Name | Description |
|---|---|---|
| DEVICE | Aortic clamp | In 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.