Aortic Valve StenosisCMILENCT01972555

Cardiac Function After Minimally Invasive Aortic Valve Implantation

A study testing Minimally invasive aortic valve replacement and Conventional aortic valve replacement in people with Aortic Valve Stenosis and Heart Valve Diseases, run by Karolinska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Stenosis, Heart Valve Diseases
What is being tested?: Minimally invasive aortic valve replacement and Conventional aortic valve replacement
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSweden
Study dates: Oct 2013to Jul 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 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

Who cannot join

Left ventricular ejection fraction less than 0.45
Presence of any coexisting severe valvular disorder
Previous cardiac surgery
Urgent or emergent surgery

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Stockholm

Other trials in Sweden

About this study

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

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.

Conditions: Aortic Valve Stenosis, Heart Valve Diseases
Being tested: Minimally invasive aortic valve replacement, Conventional aortic valve replacement
Medical subject headings: Aortic Valve Stenosis, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Minimally invasive aortic valve replacementProcedure or surgery
Conventional aortic valve replacementProcedure or surgery

Study groups in NCT01972555
Study group	Role	What they receive
Minimally invasive aortic valve replacement	Experimental	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. Receives: Procedure: Minimally invasive aortic valve replacement
Conventional aortic valve replacement	Active comparator	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. Receives: Procedure: Conventional aortic valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Jul 2015

First posted30 Oct 2013 (estimated)
Study startOct 2013
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01972555
Sponsor's protocol ID: CMILE
Acronym: CMILE
Status last verified: Aug 2016
First submitted: 21 Oct 2013
Last updated: 4 Aug 2016
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 29325064

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-center Randomized Controlled Trial of Cardiac Function After Minimally Invasive Aortic Valve Implantation (CMILE)
ClinicalTrials.gov ID: NCT01972555
Acronym / sponsor ID: CMILE / CMILE
Conditions: Aortic Valve Stenosis, Heart Valve Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Karolinska University HospitalUniversity, hospital or other
Collaborators: Karolinska Institutet
Study start: Oct 2013
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 30 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Minimally invasive aortic valve replacement	Experimental	Procedure: Minimally invasive aortic valve replacementMinimally 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 aortic valve replacement	Active comparator	Procedure: Conventional aortic valve replacementConventional 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

≥ 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

Key exclusion criteria (4 listed)

Left ventricular ejection fraction less than 0.45
Presence of any coexisting severe valvular disorder
Previous cardiac surgery
Urgent or emergent surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Minimally invasive aortic valve replacement	Procedure or surgery	Minimally invasive aortic valve replacement
Conventional aortic valve replacement	Procedure or surgery	Conventional aortic valve replacement

Primary outcome

Tricuspid Annular Peak Systolic Excursion (TAPSE)
Time frame: Preoperatively and postoperatively at day 4 and 40
Right ventricular fractional area change
Time frame: Preoperatively and postoperatively at day 4 and 40
Right ventricular dimensions
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
Derived from this study: PubMed 29325064Dalen 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.

Related trials for Aortic Valve Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
RecruitingObservational study
Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation
Severe Aortic Valve Stenosis, Valvular Heart Disease
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ulrik Sartipy, MD, PhD study chair

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital

Reidar Winter, MD, PhD study chair

Department of Cardiology, Karolinska University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tricuspid Annular Peak Systolic Excursion (TAPSE) (time frame: Preoperatively and postoperatively at day 4 and 40). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01972555, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016; AzTrials last refreshed its copy on 31 Oct 2026.