Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)

Karolinska University Hospital

Status: Completed

Conditions: Heart Valve Diseases; Aortic Valve Stenosis

Treatments: Procedure: Minimally invasive aortic valve replacement; Procedure: Conventional aortic valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT01972555

CMILE

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age
• Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
• Referred for medically indicated aortic valve replacement
• Sinus rhythm
• Provide written informed consent

Exclusion criteria

• Left ventricular ejection fraction less than 0.45
• Presence of any coexisting severe valvular disorder
• Previous cardiac surgery
• Urgent or emergent surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Minimally invasive aortic valve replacement

Experimental group

Description:

Minimally invasive AVR with either ministernotomy or anterior right-sided minithoracotomy will be performed according to current standard of care practices. Transthoracic echocardiography will be performed preoperatively and at day 1, 4, and 40.

Treatment:

Procedure: Minimally invasive aortic valve replacement

Conventional aortic valve replacement

Active Comparator group

Description:

Conventional AVR through a standard median sternotomy will be performed according to current standard of care practices. Transthoracic echocardiography will be performed preoperatively and at day 1, 4, and 40.

Treatment:

Procedure: Conventional aortic valve replacement