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Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)

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ClinicalTrials.gov Identifier: NCT01972555
Recruitment Status : Completed
First Posted : October 30, 2013
Last Update Posted : August 4, 2016
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Peter Svenarud, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE October 21, 2013
First Posted Date  ICMJE October 30, 2013
Last Update Posted Date August 4, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • Tricuspid Annular Peak Systolic Excursion (TAPSE) [ Time Frame: Preoperatively and postoperatively at day 4 and 40 ]
  • Right ventricular fractional area change [ Time Frame: Preoperatively and postoperatively at day 4 and 40 ]
  • Right ventricular dimensions [ 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
  • Left ventricular end-diastolic volume (Simpson's biplane) [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Left ventricular ejection fraction (Simpson's biplane) [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Global longitudinal strain measured by two-dimensional speckle tracking [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Mitral Annular Peak Systolic Excursion (MAPSE) [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
Change History Complete list of historical versions of study NCT01972555 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: October 24, 2013)
  • Diastolic left ventricular function [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Systolic pulmonary artery pressure [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Transaortic max/mean gradient [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Aortic valve area [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Mitral regurgitation [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Tricuspid regurgitation [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Pulmonic regurgitation [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Cardiopulmonary bypass time [ Time Frame: Peroperatively ]
  • Aortic cross-clamping time [ Time Frame: Peroperatively ]
  • In-hospital mortality [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Assisted ventilation time [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Paravalvular leakage [ Time Frame: Postoperatively at day 1, 4, and 40 ]
  • New onset atrial fibrillation [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Implantation of permanent pacemaker [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Permanent cerebrovascular accident [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Transient cerebrovascular accident [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Hemodialysis [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Pulmonary complication [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Chest tube output 12 hours after surgery [ Time Frame: 12 hours after wound closure ]
  • Reexploration for bleeding [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Reoperation for sternal wound complication [ Time Frame: 30 days after surgery ]
  • Packed red blood cells [ Time Frame: During hospital stay, an expected average of 6 days ]
  • Postoperative in-hospital length of stay [ Time Frame: During hospital stay, an expected average of 6 days ]
 
Descriptive Information
Brief Title  ICMJE Cardiac Function After Minimally Invasive Aortic Valve Implantation
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Valve Stenosis
  • Heart Valve Diseases
Intervention  ICMJE
  • Procedure: Minimally invasive aortic valve replacement
  • Procedure: Conventional aortic valve replacement
Study Arms  ICMJE
  • Experimental: Minimally invasive aortic valve replacement
    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.
    Intervention: Procedure: Minimally invasive aortic valve replacement
  • Active Comparator: Conventional aortic valve replacement
    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.
    Intervention: Procedure: Conventional aortic valve replacement
Publications * Dalén M, Oliveira Da Silva C, Sartipy U, Winter R, Franco-Cereceda A, Barimani J, Bäck M, Svenarud P. Comparison of right ventricular function after ministernotomy and full sternotomy aortic valve replacement: a randomized study. Interact Cardiovasc Thorac Surg. 2018 May 1;26(5):790-797. doi: 10.1093/icvts/ivx422.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01972555
Other Study ID Numbers  ICMJE CMILE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Svenarud, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Karolinska Institutet
Investigators  ICMJE
Study Chair: Ulrik Sartipy, MD, PhD Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Study Chair: Reidar Winter, MD, PhD Department of Cardiology, Karolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP