Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Karolinska University Hospital
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Peter Svenarud, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01972555
First received: October 21, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Aortic Valve Stenosis
Heart Valve Diseases
Procedure: Minimally invasive aortic valve replacement
Procedure: Conventional aortic valve replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Tricuspid Annular Peak Systolic Excursion (TAPSE) [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Right ventricular fractional area change [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Right ventricular dimensions [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]

Other Outcome Measures:
  • Diastolic left ventricular function [ 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 ]
  • Left ventricular ejection fraction (Simpson's biplane) [ Time Frame: Preoperatively and postoperatively at day 1, 4, and 40 ]
  • Left ventricular end-diastolic volume (Simpson's biplane) [ 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 ]

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Procedure: Conventional aortic valve replacement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972555

Contacts
Contact: Peter Svenarud, MD, PhD +46 (0) 8 517 708 12 peter.svenarud@karolinska.se

Locations
Sweden
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Peter Svenarud, MD, PhD    +46 (0) 8 517 708 12    peter.svenarud@karolinska.se   
Principal Investigator: Peter Svenarud, MD, PhD         
Sub-Investigator: Ulrik Sartipy, MD, PhD         
Sub-Investigator: Jan Liska, MD, PhD         
Sub-Investigator: Magnus Dalén, MD         
Sub-Investigator: Anders Franco-Cereceda, MD, PhD         
Sub-Investigator: Reidar Winter, MD, PhD         
Sub-Investigator: Magnus Bäck, MD, PhD         
Sub-Investigator: Cristina Oliveira Da Silva, MLS         
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
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
  More Information

No publications provided

Responsible Party: Peter Svenarud, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01972555     History of Changes
Other Study ID Numbers: CMILE
Study First Received: October 21, 2013
Last Updated: May 16, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on August 21, 2014