Aortic Valve StenosisNCT02272621
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
A study testing Minimally invasive aortic valve replacement and Full sternotomy aortic valve replacement in people with Aortic Valve Stenosis and Heart Valve Diseases, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- 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 Full sternotomy aortic valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Oct 2020
- 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
- Left ventricular ejection fraction less than 0.45
Show all 9Show fewer
- Presence of any coexisting severe valvular disorder
- Previous cardiac surgery
- Urgent or emergent surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiothoracic Surgery, Karolinska University Hospital
Stockholm
About this study
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. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.
Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding 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, Full sternotomy 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
Full sternotomy aortic valve replacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Partial upper hemisternotomy aortic valve replacement | Experimental | Partial upper hemisternotomy AVR will be performed according to current standard of care practices. Receives: Procedure: Minimally invasive aortic valve replacement |
| Full sternotomy aortic valve replacement | Experimental | Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices. Receives: Procedure: Full sternotomy aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Universal definition of perioperative bleeding in adult cardiac surgery
Measured: Within 3 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Magnus Dalén, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272621
- Sponsor's protocol ID
- CMILE-bleeding
- Status last verified
- May 2021
- First submitted
- 21 Oct 2014
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bratt S, Dimberg A, Kastengren M, Lilford RD, Svenarud P, Sartipy U, Franco-Cereceda A, Dalen M. Bleeding in minimally invasive versus conventional aortic valve replacement. J Cardiothorac Surg. 2024 Jun 21;19(1):349. doi: 10.1186/s13019-024-02667-1.
PubMed 38907320Kirmani BH, Jones SG, Muir A, Malaisrie SC, Chung DA, Williams RJ, Akowuah E. Limited versus full sternotomy for aortic valve replacement. Cochrane Database Syst Rev. 2023 Dec 6;12(12):CD011793. doi: 10.1002/14651858.CD011793.pub3.
PubMed 38054555
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT02272621
- Acronym / sponsor ID
- CMILE-bleeding
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Nov 2013 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 23 Oct 2014 (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.
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. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.
Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial upper hemisternotomy aortic valve replacement | Experimental | Procedure: Minimally invasive aortic valve replacementPartial upper hemisternotomy AVR will be performed according to current standard of care practices. |
| Full sternotomy aortic valve replacement | Experimental | Procedure: Full sternotomy aortic valve replacementFull sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 (0 listed)
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 | Partial upper hemisternotomy aortic valve replacement |
| Full sternotomy aortic valve replacement | Procedure or surgery | Full sternotomy aortic valve replacement |
Primary outcome
Universal definition of perioperative bleeding in adult cardiac surgery
Time frame: Within 3 days from surgery
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 2 Jun 2021.
- Derived from this study: PubMed 38907320Bratt S, Dimberg A, Kastengren M, Lilford RD, Svenarud P, Sartipy U, Franco-Cereceda A, Dalen M. Bleeding in minimally invasive versus conventional aortic valve replacement. J Cardiothorac Surg. 2024 Jun 21;19(1):349. doi: 10.1186/s13019-024-02667-1.
- Derived from this study: PubMed 38054555Kirmani BH, Jones SG, Muir A, Malaisrie SC, Chung DA, Williams RJ, Akowuah E. Limited versus full sternotomy for aortic valve replacement. Cochrane Database Syst Rev. 2023 Dec 6;12(12):CD011793. doi: 10.1002/14651858.CD011793.pub3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive aortic valve replacement and Full sternotomy aortic valve replacement in people with Aortic Valve Stenosis and Heart Valve Diseases, run by Karolinska University Hospital at 1 site in Sweden.
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 9 inclusion and 0 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 2 Jun 2021. 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?
Universal definition of perioperative bleeding in adult cardiac surgery (time frame: Within 3 days from surgery). 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 NCT02272621, which also lists 2 linked publications.
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 2 Jun 2021; AzTrials last refreshed its copy on 27 Oct 2026.