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

Not Applicable

Completed

• Conditions: Transaortic Transcatheter Aortic Valve Implantation
• Interventions: Device: Intra-aortic embolic protection management system; Embol-X

• Registration Number: NCT01735513
• Lead Sponsor: University Hospital, Essen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Primary Completion: 2014-04
• Study Completion: 2015-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transaortic TAVI with EmbolX	Intra-aortic embolic protection management system; Embol-X	Subjects 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	Intra-aortic embolic protection management system; Embol-X	Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation without the use of the embolic protection device "EmbolX"

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen; 🇩🇪 Essen, Germany