NCT01972555

Cardiac Function After Minimally Invasive Aortic Valve Implantation

Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. Forty patients will be randomly assigned to either minimally invasive (20 patients) or conventional AVR (20 patients). CE-marked and FDA-approved mechanical and bioprosthetic aortic valves (conventional stented or sutureless bioprostheses) will be implanted. Transthoracic echocardiography will be performed before surgery, and at day 1, 4, and 40. Echocardiographic parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Conditions

• Aortic Valve Stenosis
• Heart Valve Diseases

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive aortic valve replacement
PROCEDURE	Conventional aortic valve replacement

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-10-30
• Last updated: 2016-08-04

Locations

1 site across 1 country: Sweden