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Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)

This study has been completed.
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: August 3, 2016
Last verified: August 2016
  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 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 ]

Enrollment: 40
Study Start Date: October 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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   (Adult, Senior)
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

Locations
Sweden
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Stockholm, Sweden
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

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: August 3, 2016
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 September 23, 2016