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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

Tracking Information
First Submitted Date  ICMJE April 10, 2013
First Posted Date  ICMJE April 16, 2013
Last Update Posted Date May 5, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2013)		 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CLaret Embolic Protection ANd TAVI - Trial
Official Title  ICMJE Not Provided
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®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Frequency of Cerebral Perfusion Defects After TAVI
  • Size of Cerebral Perfusion Defects After TAVI
Intervention  ICMJE
  • Device: TAVI (Medtronic CoreValve)
  • Device: Claret-Filter
Study Arms  ICMJE
  • Cerebral Protection Filter
    Patient is treated with Cerebral protection Filter.
    Interventions:
    • Device: TAVI (Medtronic CoreValve)
    • Device: Claret-Filter
  • No Cerebral Protection Filter
    Patient is not treated with Cerebral protection Filter.
    Intervention: Device: TAVI (Medtronic CoreValve)
Publications * Haussig S, Mangner N, Dwyer MG, Lehmkuhl L, Lücke C, Woitek F, Holzhey DM, Mohr FW, Gutberlet M, Zivadinov R, Schuler G, Linke A. Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial. JAMA. 2016 Aug 9;316(6):592-601. doi: 10.1001/jama.2016.10302.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 15, 2013)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01833052
Other Study ID Numbers  ICMJE HZL-01-TAVI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. med. A. Linke, University of Leipzig
Study Sponsor  ICMJE University of Leipzig
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Leipzig
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP