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

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ClinicalTrials.gov Identifier: NCT01833052
Recruitment Status : Unknown
Verified May 2015 by Prof. Dr. med. A. Linke, University of Leipzig.
Recruitment status was:  Active, not recruiting
First Posted : April 16, 2013
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. A. Linke, University of Leipzig

Study Description
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Brief Summary:
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®.

Condition or disease Intervention/treatment Phase
Frequency of Cerebral Perfusion Defects After TAVI Size of Cerebral Perfusion Defects After TAVI Device: TAVI (Medtronic CoreValve) Device: Claret-Filter Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : April 2013
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : June 2015
Arms and Interventions
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Arm Intervention/treatment
Cerebral Protection Filter
Patient is treated with Cerebral protection Filter.
 Device: TAVI (Medtronic CoreValve)
Device: Claret-Filter
No Cerebral Protection Filter
Patient is not treated with Cerebral protection Filter.
 Device: TAVI (Medtronic CoreValve)


Outcome Measures
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Primary Outcome Measures :
  1. Rate and Size of Cerebral Embolism [ Time Frame: 2 days after Intervention ]
    Primary endpoint ist the rate and the size of cerebral embolism in postinterventional Magnetic Resonance Imaging (MRI).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833052


Locations
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Germany
Leipzig Herzzentrum
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. med. A. Linke, University of Leipzig
ClinicalTrials.gov Identifier: NCT01833052    
Other Study ID Numbers: HZL-01-TAVI
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015