Transaortic Transcatheter Aortic Valve ImplantationTAo-EmbolXNCT01735513

Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation

A study testing Intra-aortic embolic protection management system; Embol-X in people with Transaortic Transcatheter Aortic Valve Implantation, run by University Hospital, Essen at 1 site in Germany.

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

Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve implantation by the use of an embolic protection device. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Transaortic Transcatheter Aortic Valve Implantation
What is being tested?: Intra-aortic embolic protection management system; Embol-X
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteGermany
Study dates: Jul 2012to Sep 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

Patients with symptomatic severe aortic valve stenosis (valve area <0.8 cm2) are considered candidates for TAVI (TAVR) if they have a logistic European System for Cardiac Operative Risk Evaluation score (EuroSCORE) ≥15% or surgery is deemed to be at excessive risk because of comorbidities and other risk factors not being captured by these scoring systems. Indication for TAVI in the individual patient is discussed in a consensus conference of cardiologists and cardiac surgeons, and patient's or physician's preference alone is not considered adequate for decision making. The performance of TAVI in these patients is approved by the local authorities. All patients have to agree to participate in the study, and written informed consent is obtained.

Who cannot join

Patients are excluded from TAVI (TAVR) in the presence of any of the following conditions:
bicuspid aortic valve
aortic annulus diameter ≤18 or ≥27 mm
procelain aorta
unprotected left main disease
recent myocardial infarction or cerebrovascular event

Show all 12Show fewer

sepsis or active endocarditis
severe aortic atheroma
left ventricular or atrial thrombus
active peptic ulcer
bleeding diathesis
hypersensitivity to antiplatelet therapy

Trial locations and contacts

1 site in 1 country.

Germany1 site

Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen
Essen, 45122

Other trials in Germany

About this study

Official title: Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation: a Randomized-controlled Trial

Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve implantation by the use of an embolic protection device.

Conditions: Transaortic Transcatheter Aortic Valve Implantation
Being tested: Intra-aortic embolic protection management system; Embol-X
Keywords: transaortic TAVI or TAVR, embolic protection device, EmbolX, efficacy, during transaortic TAVI, reduce the incidence of new foci of restricted diffusion on diffusion-weighted MRI

What participants receive

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

Intra-aortic embolic protection management system; Embol-XDevice
Also called Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.
The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients "embolic showers" which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.

Study groups in NCT01735513
Study group	Role	What they receive
Transaortic TAVI with EmbolX	Experimental	Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation with the use of the embolic protection device "EmbolX" Receives: Device: Intra-aortic embolic protection management system; Embol-X
Transaortic TAVI without EmbolX	Active comparator	Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation without the use of the embolic protection device "EmbolX" Receives: Device: Intra-aortic embolic protection management system; Embol-X

What is being measured

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

The detection of new morphological brain injury with new hyper-intense DW-MRI cerebral lesions on the post-treatment compared to the pretreatment MRI imaging
MRI of the brain is obtained at the same time as clinical exams. Scans are performed on a 1.5-T MR unit and a circular polarized head coil. The imaging protocol includes a transversal DW, single shot echo-planar sequence of the whole brain. Diffusion images are processed to generate isotopic apparent diffusion coefficient maps using dedicated software allowing for proper classification of the lesions. Transversal fluid-attenuated inversion recovery and transversal T2-weighted turbo spin-echo sequences are also performed. Slice thickness is 5mm for all sequences. Scans are read by an experienced neuroradiologist blinded to the clinical data. The presence, number, volume and location of all new focal diffusion abnormalities were recorded.
Measured: Postoperative day 1-3

Secondary outcomes (1)

Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment
Stroke and transient ischaemic attack is defined according to the Valve Academic Research Consortium (VARC) recommendation. In case of stroke, the modified Rankin scale (mRS) is assessed to categorize the patient's level of functional independence during daily activities.
Measured: 30 days after treatment

Timeline

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

Jul 2012Sep 2015

First posted28 Nov 2012 (estimated)
Study startJul 2012
Primary completionApr 2014
Study completionSep 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 Transaortic Transcatheter Aortic Valve ImplantationStudies 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: Single group
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01735513
Sponsor's protocol ID: WDHZ-TC-TAo-EmbolX
Acronym: TAo-EmbolX
Status last verified: May 2016
First submitted: 22 Nov 2012
Last updated: 12 May 2016
Results posted: No
Data monitoring committee: No

Publications

Wendt D, Kleinbongard P, Knipp S, Al-Rashid F, Gedik N, El Chilali K, Schweter S, Schlamann M, Kahlert P, Neuhauser M, Forsting M, Erbel R, Heusch G, Jakob H, Thielmann M. Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation. Ann Thorac Surg. 2015 Aug;100(2):686-91. doi: 10.1016/j.athoracsur.2015.03.119.
PubMed 26234838

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation: a Randomized-controlled Trial
ClinicalTrials.gov ID: NCT01735513
Acronym / sponsor ID: TAo-EmbolX / WDHZ-TC-TAo-EmbolX
Conditions: Transaortic Transcatheter Aortic Valve Implantation
Keywords: transaortic TAVI or TAVR, embolic protection device, EmbolX, efficacy, during transaortic TAVI, reduce the incidence of new foci of restricted diffusion on diffusion-weighted MRI
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University Hospital, EssenUniversity, hospital or other
Study start: Jul 2012
Primary completion: Apr 2014 (actual)
Study completion: Sep 2015 (actual)
First posted: 28 Nov 2012 (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 hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve implantation by the use of an embolic protection device.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Transaortic TAVI with EmbolX	Experimental	Device: Intra-aortic embolic protection management system; Embol-XSubjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation with the use of the embolic protection device "EmbolX"
Transaortic TAVI without EmbolX	Active comparator	Device: Intra-aortic embolic protection management system; Embol-XSubjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation without the use of the embolic protection device "EmbolX"

Who may qualify

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

Key inclusion criteria (1 listed)

Patients with symptomatic severe aortic valve stenosis (valve area <0.8 cm2) are considered candidates for TAVI (TAVR) if they have a logistic European System for Cardiac Operative Risk Evaluation score (EuroSCORE) ≥15% or surgery is deemed to be at excessive risk because of comorbidities and other risk factors not being captured by these scoring systems. Indication for TAVI in the individual patient is discussed in a consensus conference of cardiologists and cardiac surgeons, and patient's or physician's preference alone is not considered adequate for decision making. The performance of TAVI in these patients is approved by the local authorities. All patients have to agree to participate in the study, and written informed consent is obtained.

Key exclusion criteria (12 listed)

Patients are excluded from TAVI (TAVR) in the presence of any of the following conditions:
bicuspid aortic valve
aortic annulus diameter ≤18 or ≥27 mm
procelain aorta
unprotected left main disease

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
Intra-aortic embolic protection management system; Embol-XAlso: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients "embolic showers" which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.	Device	Transaortic TAVI with EmbolX, Transaortic TAVI without EmbolX

Primary outcome

The detection of new morphological brain injury with new hyper-intense DW-MRI cerebral lesions on the post-treatment compared to the pretreatment MRI imaging
Time frame: Postoperative day 1-3
MRI of the brain is obtained at the same time as clinical exams. Scans are performed on a 1.5-T MR unit and a circular polarized head coil. The imaging protocol includes a transversal DW, single shot echo-planar sequence of the whole brain. Diffusion images are processed to generate isotopic apparent diffusion coefficient maps using dedicated software allowing for proper classification of the lesions. Transversal fluid-attenuated inversion recovery and transversal T2-weighted turbo spin-echo sequences are also performed. Slice thickness is 5mm for all sequences. Scans are read by an experienced neuroradiologist blinded to the clinical data. The presence, number, volume and location of all new focal diffusion abnormalities were recorded.

1 secondary outcome

Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment
Time frame: 30 days after treatment

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 12 May 2016.
Derived from this study: PubMed 26234838Wendt D, Kleinbongard P, Knipp S, Al-Rashid F, Gedik N, El Chilali K, Schweter S, Schlamann M, Kahlert P, Neuhauser M, Forsting M, Erbel R, Heusch G, Jakob H, Thielmann M. Intraaortic Protection From Embolization in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation. Ann Thorac Surg. 2015 Aug;100(2):686-91. doi: 10.1016/j.athoracsur.2015.03.119.

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 Intra-aortic embolic protection management system; Embol-X in people with Transaortic Transcatheter Aortic Valve Implantation, run by University Hospital, Essen at 1 site in Germany.

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 1 inclusion and 12 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 12 May 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 Germany. 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?

The detection of new morphological brain injury with new hyper-intense DW-MRI cerebral lesions on the post-treatment compared to the pretreatment MRI imaging (time frame: Postoperative day 1-3). 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 NCT01735513, 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 12 May 2016.