Clinical trial NCT01735513: Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation
Official title: Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
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
timeFrame: Postoperative day 1-3
Secondary outcomes:
measure: Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment
timeFrame: 30 days after treatment
Other outcomes:
measure: Neurocognitive function postoperatively compared to preoperative status
timeFrame: at baseline before treatment and at 1-3 days after treatment, at discharge and at 3 months
Locations:
city: Essen
country: Germany
facility: Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen
Study officials:
References:
citation: 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.