European Study Evaluating the EMBLOK Embolic Protection System During TAVR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2022-01-28

Brief Summary

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The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI.

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Detailed Description

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The enrollment of up to thirty subjects with severe native aortic valve stenosis who meet clinically approved indications for transcatheter aortic valve replacement. The primary objective evaluates performance and treatment effect of the use of the EMBLOK. A secondary objective of this study is to analyze the safety profile and the type of captured debris from the Emblok filter after TAVR. Due to the small sample size, the study is not powered to detect a reduction in actual stroke rates. However, the potential risk of stroke will be assessed based on neurological evaluations pre and post procedure. In addition, silent ischemic damage and cerebral embolic burden will be assessed using DW MRI studies.

Conditions

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Aortic Valve Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TAVR + Embolic protection

subjects with severe native aortic valve stenosis who meet the commercially approved indications for transcatheter aortic valve replacement

Group Type OTHER

Transcatheter Aortic Valve Replacement (TAVR)

Intervention Type PROCEDURE

placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement

EMBLOK filter

Intervention Type DEVICE

Embolic Filter Protection System During TAVR

Interventions

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Transcatheter Aortic Valve Replacement (TAVR)

placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement

Intervention Type PROCEDURE

EMBLOK filter

Embolic Filter Protection System During TAVR

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject's legal representative completes written Informed Consent.

Exclusion Criteria

Subject has experienced a myocardial infarction within 30 days of the planned index procedure.

Subject has renal insufficiency, defined as a creatinine level \> 2.5 mg/dl at the time of treatment.

Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.

Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.

Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature \> 38° C and/ or WBC \> 15,000 IU.

Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No