Aortic Valve StenosisPhase 4AKE-MECCNCT02308566

Cerebral Embolic Load in Patients Undergoing Surgical Aortic Valve Replacement: A Comparison of the Conventional With the Minimized Extracorporeal Circulation Technique Using Transcranial Doppler Ultrasound

A Phase 4 study testing Minimized Extracorporeal Circulation (MECC) and Conventional Extracorporeal Circulation (CECC) in people with Aortic Valve Stenosis and Extracorporeal Circulation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

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 to 80 years
Conditions the study is for: Aortic Valve Stenosis, Extracorporeal Circulation
What is being tested?: Minimized Extracorporeal Circulation (MECC) and Conventional Extracorporeal Circulation (CECC)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteSwitzerland
Study dates: Jun 2011to Jun 2016
Phase: Phase 4
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Isolated Severe Aortic Valve Stenosis
No other cardiac disease
No other coronary heart disease
Written informed consent

Who cannot join

Double valve surgery
Concomitant coronary artery bypass surgery
Vascular surgery
Age < 18 yrs.
Age > 80 yrs.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University Hospital Bern
Bern, 3010

Other trials in Switzerland

About this study

Official title: Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences

In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation technique. The detection of cerebral emboli is performed not-invasively by transcranial Doppler detection of high-intensity transient signals representing solid or gaseous microembolism in the middle cerebral arteries. The investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism during aortic valve surgery using extracorporeal circulation.

Read the detailed description

Background

The gold standard to treat severe aortic valve stenosis is currently the surgical aortic valve replacement (SAVR) using conventional extracorporeal circulation (CECC). SAVR, however, can be performed also on minimized extracorporeal circulation (MECC), which is characterized by reduced priming volume and interfaces between blood and artificial surfaces and blood-air interface, respectively. Further technical developments of the MECC system together with reports on less induction of the coagulation cascade and activation of inflammatory systemic response may account for a reduced incidence of microbubble generation with MECC system.

Objective

The aim of the is to investigate the procedural-related incidence of high-intensity transient signals (HITS) representing solid or gaseous microembolism reaching the cerebral vessels.

Methods

Patients undergoing SAVR are included in the study and randomised to either MECC or CECC technique. HITS are continuously bilaterally detected during the entire intraoperative period by transcranial Doppler ultrasound.

Conditions: Aortic Valve Stenosis, Extracorporeal Circulation
Being tested: Minimized Extracorporeal Circulation (MECC), Conventional Extracorporeal Circulation (CECC)
Keywords: Intracranial Embolism, Ultrasonography, Doppler, Transcranial
Medical subject headings: Aortic Valve Stenosis, Intracranial Embolism

What participants receive

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

Minimized Extracorporeal Circulation (MECC)Procedure or surgery
This group of patients receives surgical aortic valve replacement using MECC.
Conventional Extracorporeal Circulation (CECC)Procedure or surgery
This group of patients receives surgical aortic valve replacement using CECC.

Study groups in NCT02308566
Study group	Role	What they receive
Conventional Extracorporeal Circulation Technique	Active comparator	Conventional Extracorporeal Circulation Technique Receives: Procedure: Conventional Extracorporeal Circulation (CECC)
Minimized Extracorporeal Circulation Technique	Experimental	Minimized Extracorporeal Circulation Technique Receives: Procedure: Minimized Extracorporeal Circulation (MECC)

What is being measured

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

Total and interval-related cerebral microembolic load as measured by transcranial Doppler
Measured: Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)

Secondary outcomes (7)

Cerebral complications, e.g. delirium and stroke as detected clinically
Measured: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Redo surgery
Measured: In-hospital period (until hospital discharge, duration approx. 7-10 days)
ICU length of stay
Measured: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Extubation time
Measured: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Thromboembolic complications
Measured: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital infections
Measured: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital Mortality
Measured: In-hospital period (until hospital discharge, duration approx. 7-10 days)

Timeline

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

Jun 2011Jun 2016

First posted4 Dec 2014 (estimated)
Study startJun 2011
Primary completionMar 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02308566
Sponsor's protocol ID: 034/11
Acronym: AKE-MECC
Status last verified: Jun 2016
First submitted: 2 Dec 2014
Last updated: 30 Jun 2016
Results posted: No
Data monitoring committee: No

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

Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances

All Aortic Valve Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
ClinicalTrials.gov ID: NCT02308566
Acronym / sponsor ID: AKE-MECC / 034/11
Conditions: Aortic Valve Stenosis, Extracorporeal Circulation
Keywords: Intracranial Embolism, Ultrasonography, Doppler, Transcranial
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Insel Gruppe AG, University Hospital BernUniversity, hospital or other
Study start: Jun 2011
Primary completion: Mar 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 4 Dec 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.

Detailed description

Background

Objective

The aim of the is to investigate the procedural-related incidence of high-intensity transient signals (HITS) representing solid or gaseous microembolism reaching the cerebral vessels.

Methods

Study design

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

Arm	Type	Receives
Conventional Extracorporeal Circulation Technique	Active comparator	Procedure: Conventional Extracorporeal Circulation (CECC)Conventional Extracorporeal Circulation Technique
Minimized Extracorporeal Circulation Technique	Experimental	Procedure: Minimized Extracorporeal Circulation (MECC)Minimized Extracorporeal Circulation Technique

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Isolated Severe Aortic Valve Stenosis
No other cardiac disease
No other coronary heart disease
Written informed consent

Key exclusion criteria (5 listed)

Double valve surgery
Concomitant coronary artery bypass surgery
Vascular surgery
Age < 18 yrs.
Age > 80 yrs.

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
Minimized Extracorporeal Circulation (MECC)This group of patients receives surgical aortic valve replacement using MECC.	Procedure or surgery	Minimized Extracorporeal Circulation Technique
Conventional Extracorporeal Circulation (CECC)This group of patients receives surgical aortic valve replacement using CECC.	Procedure or surgery	Conventional Extracorporeal Circulation Technique

Primary outcome

Total and interval-related cerebral microembolic load as measured by transcranial Doppler
Time frame: Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)

7 secondary outcomes

Cerebral complications, e.g. delirium and stroke as detected clinically
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Redo surgery
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
ICU length of stay
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Extubation time
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
Thromboembolic complications
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital infections
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)
In-hospital Mortality
Time frame: In-hospital period (until hospital discharge, duration approx. 7-10 days)

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 30 Jun 2016.

Related trials for Aortic Valve Stenosis

Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Systematic Ambulatory ECG Monitoring Following TAVI
Aortic Stenosis, Conduction Disturbances

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.

Thierry Carrel, MD, PhD principal investigator

Department of Cardiovascular Surgery

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 4 inclusion and 5 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 30 Jun 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 Switzerland. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Total and interval-related cerebral microembolic load as measured by transcranial Doppler (time frame: Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs)). 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 NCT02308566.

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 30 Jun 2016.