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Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01196923
First received: September 7, 2010
Last updated: June 16, 2016
Last verified: June 2016
Results First Received: April 18, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Intervention: Device: Endoscopically Guided Ablation

  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
HeartLight Ablation Pulmonary Vein Isolation with the HeartLight System

Participant Flow:   Overall Study
    HeartLight Ablation
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
HeartLight Ablation Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants.

Baseline Measures
   HeartLight Ablation 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age, Customized 
[Units: Years]
Mean (Full Range)
 
Average age, reported data   59 
 (43 to 74) 
Gender 
[Units: Participants with data available]
 
Female   3 
Male   16 
Region of Enrollment 
[Units: Participants]
 
Italy   20 


  Outcome Measures

1.  Primary:   Acute Isolation of Pulmonary Veins.   [ Time Frame: Acute PVI measured on the day of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Burke Barrett, VP, Regulatory & Clinical Affairs
Organization: CardioFocus, Inc.
phone: 508 658-7200
e-mail: bbarrett@cardiofocus.com



Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01196923     History of Changes
Other Study ID Numbers: 25-2858
Study First Received: September 7, 2010
Results First Received: April 18, 2016
Last Updated: June 16, 2016
Health Authority: Italy: Ministry of Health