CLaret Embolic Protection ANd TAVI - Trial (CLEAN-TAVI)

University of Leipzig

Status: Unknown

Conditions: Size of Cerebral Perfusion Defects After TAVI; Frequency of Cerebral Perfusion Defects After TAVI

Treatments: Device: Claret-Filter; Device: TAVI (Medtronic CoreValve)

Study type: Interventional

Funder types: Other

Identifiers

NCT01833052

HZL-01-TAVI

Details and patient eligibility

About

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®.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Cerebral Protection Filter

Other group

Description:

Patient is treated with Cerebral protection Filter.

Treatment:

Device: Claret-Filter

Device: TAVI (Medtronic CoreValve)

No Cerebral Protection Filter

Other group

Description:

Patient is not treated with Cerebral protection Filter.

Treatment:

Device: TAVI (Medtronic CoreValve)