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

Purpose

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

Condition	Intervention
Transaortic Transcatheter Aortic Valve Implantation	Device: Intra-aortic embolic protection management system; Embol-X

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation: a Randomized-controlled Trial

Further study details as provided by University Hospital, Essen:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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.

Other Outcome Measures:

Neurocognitive function postoperatively compared to preoperative status [ Time Frame: at baseline before treatment and at 1-3 days after treatment, at discharge and at 3 months ] [ Designated as safety issue: Yes ]
Examinations were performed at baseline, pre-discharge and 3 months thereafter. Neurological status is assessed by a detailed clinical examination protocol. Cognitive function is evaluated using three different standardized neuropsychological tests and the Mini-Mental State Examination (MMSE).

Estimated Enrollment:	50
Study Start Date:	July 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Transaortic TAVI with EmbolX Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation with the use of the embolic protection device "EmbolX"	Device: Intra-aortic embolic protection management system; Embol-X 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. Other Name: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.
Active Comparator: Transaortic TAVI without EmbolX Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation without the use of the embolic protection device "EmbolX"	Device: Intra-aortic embolic protection management system; Embol-X 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. Other Name: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.

Arms

Assigned Interventions

Experimental: Transaortic TAVI with EmbolX

Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation with the use of the embolic protection device "EmbolX"

Device: Intra-aortic embolic protection management system; Embol-X

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.

Other Name: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.

Active Comparator: Transaortic TAVI without EmbolX

Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation without the use of the embolic protection device "EmbolX"

Device: Intra-aortic embolic protection management system; Embol-X

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.

Other Name: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735513

Locations

Germany
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen	Recruiting
Essen, Germany, 45122
Contact: Matthias Thielmann, MD, PhD matthias.thielmann@uni-due.de
Contact: Wolfgang Ristau +49-201-723-84927 wolfgang.ristau@uk-essen.de
Principal Investigator: Matthias Thielmann, MD, PhD
Sub-Investigator: Philipp Kahlert, MD
Sub-Investigator: Daniel Wendt, MD
Sub-Investigator: Stephan Knipp, MD

Sponsors and Collaborators

University Hospital, Essen

More Information

No publications provided

Responsible Party:	Matthias Thielmann, PD. Dr. med. Matthias Thielmann, West German Heart Center Essen
ClinicalTrials.gov Identifier:	NCT01735513 History of Changes
Other Study ID Numbers:	WDHZ-TC-TAo-EmbolX
Study First Received:	November 22, 2012
Last Updated:	November 27, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Essen:

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

ClinicalTrials.gov processed this record on May 16, 2013

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