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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01196923
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Intervention: Device: Endoscopically Guided Ablation

  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
HeartLight Ablation Pulmonary Vein Isolation with the HeartLight System

Participant Flow:   Overall Study
    HeartLight Ablation

  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.
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Reporting Groups
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]
Age, Customized 
[Units: Years]
Mean (Full Range)
Average age, reported data   59 
 (43 to 74) 
[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

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 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

Responsible Party: CardioFocus Identifier: NCT01196923     History of Changes
Other Study ID Numbers: 25-2858
First Submitted: September 7, 2010
First Posted: September 9, 2010
Results First Submitted: April 18, 2016
Results First Posted: July 27, 2016
Last Update Posted: July 27, 2016