Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Karolinska University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Right ventricular fractional area change
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Peter Svenarud
MD, PhD
Karolinska University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Right ventricular fractional area change
Time Frame: Preoperatively and postoperatively at day 4 and 40
Pulsed wave tissue Doppler right venricular velocity
Time Frame: Preoperatively and postoperatively at day 4 and 40
Tricuspid Annular Peak Systolic Excursion (TAPSE)
Time Frame: Preoperatively and postoperatively at day 4 and 40
Right ventricular dimensions
Time Frame: Preoperatively and postoperatively at day 4 and 40