Cardiac Function After Minimally Invasive Aortic Valve Implantation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01972555

Acronym

CMILE

Enrollment

Registered

2013-10-30

Start date

2013-10-31

Completion date

2015-07-31

Last updated

2016-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Heart Valve Diseases

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.

Interventions

PROCEDUREMinimally invasive aortic valve replacement

PROCEDUREConventional aortic valve replacement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026