Viewing Study NCT04231903



Ignite Creation Date: 2024-05-06 @ 2:10 PM
Last Modification Date: 2024-10-26 @ 1:26 PM
Study NCT ID: NCT04231903
Status: COMPLETED
Last Update Posted: 2020-01-18
First Post: 2020-01-05

Brief Title: Myocardial Protection in Minimally Invasive Mitral Valve Surgery
Sponsor: University of Turin Italy
Organization: University of Turin Italy

Study Overview

Official Title: Endo-aortic Versus Trans-thoracic Clamping in Right Mini-thoracotomy Mitral Valve Repair Outcome on Myocardial Pro-tection
Status: COMPLETED
Status Verified Date: 2020-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None