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Completed

NCT Number: NCT01972555

Cardiac Function After Minimally Invasive Aortic Valve Implantation

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive aortic valve replacement

Procedure

Conventional aortic valve replacement

Procedure

Primary outcomes

  1. Tricuspid Annular Peak Systolic Excursion (TAPSE)

    Time frame: Preoperatively and postoperatively at day 4 and 40

  2. Right ventricular fractional area change

    Time frame: Preoperatively and postoperatively at day 4 and 40

  3. Right ventricular dimensions

    Time frame: Preoperatively and postoperatively at day 4 and 40

  4. Pulsed wave tissue Doppler right venricular velocity

    Time frame: Preoperatively and postoperatively at day 4 and 40

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: CMILE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2013
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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