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Evaluation of the Incidence of Cerebral Lesions Post Pulmonary Vein Ablation Catheter (PVAC) (ERACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01520532
First received: January 25, 2012
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
Results First Received: December 10, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Atrial Fibrillation
Intervention: Other: Magnetic Resonance Imaging (MRI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ablation Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).

Participant Flow:   Overall Study
    Ablation  
STARTED     60 [1]
COMPLETED     60  
NOT COMPLETED     0  
[1] Subjects who underwent an ablation and had post-procedure MRI



  Baseline Characteristics
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Reporting Groups
  Description
Ablation No text entered.

Baseline Measures
    Ablation  
Number of Participants  
[units: participants]
 		  60  
Age  
[units: years]
Mean ± Standard Deviation 		  60  ± 10  
Gender  
[units: participants]
 		 
Female     19  
Male     41  
Region of Enrollment  
[units: participants]
 		 
Canada     12  
Belgium     13  
Germany     12  
Netherlands     12  
Italy     11  



  Outcome Measures
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1.  Primary:   New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.   [ Time Frame: Within 1-3 days post ablation ]
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2.  Secondary:   Acute Safety Events   [ Time Frame: 30 days ]
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3.  Secondary:   Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.   [ Time Frame: Day 1 (End of Procedure) ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Jay Kelley, Director of Clinical Research
Organization: Medtronic AF Solutions
phone: +1.760.827.0076
e-mail: jay.l.kelley@medtronic.com


No publications provided


Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01520532     History of Changes
Other Study ID Numbers: MDT-AFS-ERACE
Study First Received: January 25, 2012
Results First Received: December 10, 2012
Last Updated: February 12, 2013
Health Authority: Belgium: Ethics Committee