Myocardial Protection in Minimally Invasive Mitral Valve Surgery

Mitral Valve Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231903
• Other study ID #: 0063123
• Status: Completed
• Start date: June 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2020
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Minimally Invasive Surgery
• Mitral Valve Prolapse
• Myocardial Protection
• Prolapse

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cTn-T levels immediately after surgery	Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping	Immediately after surgery
Primary	CK-MB levels immediately 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	Immediately after the surgery
Primary	cTn-T levels 6h	Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping	hour 6 after surgery
Primary	CK-MB levels 6h	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	hour 6 after surgery
Primary	cTn-T levels 12h	Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping	hour 12 after surgery
Primary	CK-MB levels 12h	(CK-MB) blood levels after right mini-thoracotomy mitral valve surgery and compared between the 2 groups of aortic clamping	hour 12 after surgery
Primary	cTn-T levels 24h	Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping	hour 24 after surgery
Primary	CK-MB levels 24h	Myocardial protection was assessed through cardiac Troponin T (cTn-T) blood levels and compared between the 2 groups of aortic clamping	hour 24 after surgery