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

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ClinicalTrials.gov Identifier: NCT01520532
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : March 14, 2013
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Atrial Fibrillation
Intervention: Other: Magnetic Resonance Imaging (MRI)

  Participant Flow

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ablation No text entered.

Baseline Measures
   Ablation 
Overall Participants Analyzed 
[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

1.  Primary:   New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.   [ Time Frame: Within 1-3 days post ablation ]

2.  Secondary:   Acute Safety Events   [ Time Frame: 30 days ]

3.  Secondary:   Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.   [ Time Frame: Day 1 (End of Procedure) ]


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

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.


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


Publications of Results:

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01520532     History of Changes
Other Study ID Numbers: MDT-AFS-ERACE
First Submitted: January 25, 2012
First Posted: January 30, 2012
Results First Submitted: December 10, 2012
Results First Posted: March 14, 2013
Last Update Posted: September 19, 2013