Skip to main content
Clinical Trials/NCT01972555
NCT01972555
Completed
Not Applicable

Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)

Karolinska University Hospital1 site in 1 country40 target enrollmentOctober 2013

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
July 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

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

Study Sites (1)

Loading locations...

Similar Trials