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

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

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

Study Overview

• Status: Completed
• Conditions: Transaortic Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Device: Intra-aortic embolic protection management system; Embol-X

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany, 45122
    • Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Postoperative day 1-3

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurocognitive function postoperatively compared to preoperative status	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).	at baseline before treatment and at 1-3 days after treatment, at discharge and at 3 months

Collaborators and Investigators

• Sponsor: University Hospital, Essen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: efficacy; embolic protection device; transaortic TAVI or TAVR; EmbolX; during transaortic TAVI; reduce the incidence of new foci of restricted diffusion on diffusion-weighted MRI
• Other Study ID Numbers: WDHZ-TC-TAo-EmbolX