Completed

NCT Number: NCT01735513

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

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

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Key information

Conditions

Transaortic Transcatheter Aortic Valve Implantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Essen, 45122, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-aortic embolic protection management system; Embol-X

Device

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

Primary outcomes

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.

Secondary outcomes

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

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 outcomes

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

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).

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Acronym: TAo-EmbolX

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Nov 28, 2012
Registry last updated: May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.