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

University Hospital Essen

Status: Completed

Conditions: Transaortic Transcatheter Aortic Valve Implantation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01735513

WDHZ-TC-TAo-EmbolX

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Transaortic TAVI with EmbolX

Experimental group

Description:

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

Treatment:

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

Transaortic TAVI without EmbolX

Active Comparator group

Description:

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

Treatment:

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