Cardiac Function After Minimally Invasive Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

— CMILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972555
• Other study ID #: CMILE
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: August 3, 2016
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Heart Valve Diseases

Intervention

Procedure:
• Minimally invasive aortic valve replacement

• Conventional aortic valve replacement

Locations

Country	Name	City	State
Sweden	Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tricuspid Annular Peak Systolic Excursion (TAPSE)		Preoperatively and postoperatively at day 4 and 40
Primary	Right ventricular fractional area change		Preoperatively and postoperatively at day 4 and 40
Primary	Right ventricular dimensions		Preoperatively and postoperatively at day 4 and 40
Primary	Pulsed wave tissue Doppler right venricular velocity		Preoperatively and postoperatively at day 4 and 40