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Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)

Primary Purpose

Aortic Valve Stenosis, Heart Valve Diseases

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Minimally invasive aortic valve replacement
Conventional aortic valve replacement
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minimally invasive aortic valve replacement

Conventional aortic valve replacement

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tricuspid Annular Peak Systolic Excursion (TAPSE)
Right ventricular fractional area change
Right ventricular dimensions
Pulsed wave tissue Doppler right venricular velocity

Secondary Outcome Measures

Full Information

First Posted
October 21, 2013
Last Updated
August 3, 2016
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01972555
Brief Title
Cardiac Function After Minimally Invasive Aortic Valve Implantation
Acronym
CMILE
Official Title
Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Heart Valve Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimally invasive aortic valve replacement
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional aortic valve replacement
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive aortic valve replacement
Intervention Type
Procedure
Intervention Name(s)
Conventional aortic valve replacement
Primary Outcome Measure Information:
Title
Tricuspid Annular Peak Systolic Excursion (TAPSE)
Time Frame
Preoperatively and postoperatively at day 4 and 40
Title
Right ventricular fractional area change
Time Frame
Preoperatively and postoperatively at day 4 and 40
Title
Right ventricular dimensions
Time Frame
Preoperatively and postoperatively at day 4 and 40
Title
Pulsed wave tissue Doppler right venricular velocity
Time Frame
Preoperatively and postoperatively at day 4 and 40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Sartipy, MD, PhD
Organizational Affiliation
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Reidar Winter, MD, PhD
Organizational Affiliation
Department of Cardiology, Karolinska University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29325064
Citation
Dalen M, Oliveira Da Silva C, Sartipy U, Winter R, Franco-Cereceda A, Barimani J, Back M, Svenarud P. Comparison of right ventricular function after ministernotomy and full sternotomy aortic valve replacement: a randomized study. Interact Cardiovasc Thorac Surg. 2018 May 1;26(5):790-797. doi: 10.1093/icvts/ivx422.
Results Reference
derived

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Cardiac Function After Minimally Invasive Aortic Valve Implantation

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