CLaret Embolic Protection ANd TAVI

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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This prospective, randomized study was designed to investigate the benefit of using a Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic valve implantation (TAVI) with a Medtronic CoreValve®.

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Detailed Description

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Conditions

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Frequency of Cerebral Perfusion Defects After TAVI Size of Cerebral Perfusion Defects After TAVI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cerebral Protection Filter

Patient is treated with Cerebral protection Filter.

Group Type OTHER

TAVI (Medtronic CoreValve)

Intervention Type DEVICE

Claret-Filter

Intervention Type DEVICE

No Cerebral Protection Filter

Patient is not treated with Cerebral protection Filter.

Group Type OTHER

TAVI (Medtronic CoreValve)

Intervention Type DEVICE

Interventions

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TAVI (Medtronic CoreValve)

Intervention Type DEVICE

Claret-Filter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject must be scheduled to undergo an endovascular aortic valve prosthesis (Medtronic CoreValve®) implant procedure with the femoral artery as the intended access site for the valve delivery system.

Exclusion Criteria

* Patient is unsuitable for TAVI
* Prior Stroke or TIA in the last 12 month
* Carotic stenosis \>70%
* Relevant stenosis of the brachiocephalic trunc or the right subclavian artery
* Expected Non-compliance for follow-ups
* Pregnancy
* Patient is already recruited for another study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No