CLaret Embolic Protection ANd TAVI - Trial

University of Leipzig100 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

100

Conditions

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

Interventions

TAVI (Medtronic CoreValve)DEVICE

Claret-FilterDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Leipzig Herzzentrum

Leipzig, Germany

Outcomes

Primary Outcomes

Rate and Size of Cerebral Embolism

Primary endpoint ist the rate and the size of cerebral embolism in postinterventional Magnetic Resonance Imaging (MRI).

Time frame: 2 days after Intervention

Data from ClinicalTrials.gov

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