Cardiac Function After Minimally Invasive Aortic Valve Implantation

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Valve Stenosis, Heart Valve Diseases

Intervention / Treatment
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* Procedure: Minimally invasive aortic valve replacement
* Procedure: Conventional aortic valve replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive aortic valve replacement<br>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. | Procedure: Minimally invasive aortic valve replacement<br> <br> |
| Active Comparator: Conventional aortic valve replacement<br>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. | Procedure: Conventional aortic valve replacement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tricuspid Annular Peak Systolic Excursion (TAPSE) |  | Preoperatively and postoperatively at day 4 and 40 | 
| Right ventricular fractional area change |  | Preoperatively and postoperatively at day 4 and 40 | 
| Right ventricular dimensions |  | Preoperatively and postoperatively at day 4 and 40 | 
| Pulsed wave tissue Doppler right venricular velocity |  | Preoperatively and postoperatively at day 4 and 40 |