Brief Title
Cardiac Function After Minimally Invasive Aortic Valve Implantation
Official Title
Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)
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.
Study Type
Interventional
Primary Outcome
Tricuspid Annular Peak Systolic Excursion (TAPSE)
Condition
Aortic Valve Stenosis
Intervention
Minimally invasive aortic valve replacement
Study Arms / Comparison Groups
Minimally invasive aortic valve replacement
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
40
Start Date
October 2013
Completion Date
July 2015
Primary Completion Date
July 2015
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ulrik Sartipy, MD, PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT01972555
Organization ID
CMILE
Responsible Party
Principal Investigator
Study Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
Study Sponsor
Ulrik Sartipy, MD, PhD, Study Chair, Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Verification Date
August 2016