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HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF) (HeartLight)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01456000
First received: October 17, 2011
Last updated: July 25, 2016
Last verified: July 2016
Results First Received: April 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Paroxysmal Atrial Fibrillation
Interventions: Device: EAS-AC (HeartLight)
Procedure: Control Arm 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
There were 405 participants enrolled in the study. Thirty nine of these participants were enrolled in the run-in phase and are not reported in the pivotal data. Of the remaining 366 enrolled participants, 13 were excluded from the study prior to randomization, resulting in a total of 353 randomized participants.

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
EAS-AC (HeartLight)

Treatment with the EAS-AC.

EAS-AC (HeartLight): Pulmonary vien isolation

ITT Population 178 participants

Control Arm Ablation

Treatment with standard ablation.

Control Arm Ablation: Treatment with standard ablation.

ITT Population 175 Participants


Participant Flow:   Overall Study
    EAS-AC (HeartLight)   Control Arm Ablation
STARTED   178   175 
COMPLETED   170   172 
NOT COMPLETED   8   3 



  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.
Average Age

Reporting Groups
  Description
EAS-AC (HeartLight)

Treatment with the EAS-AC. Randomized and treated cohort.

EAS-AC (HeartLight): Pulmonary vien isolation

Control Arm Ablation

Treatment with standard ablation. Randomized and treated cohort.

Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation.

Total Total of all reporting groups

Baseline Measures
   EAS-AC (HeartLight)   Control Arm Ablation   Total 
Overall Participants Analyzed 
[Units: Participants]
 170   172   342 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
     
Age   59.7  (10.4)   60.1  (8.9)   59.9  (9.7) 
Gender 
[Units: Participants]
     
Female   52   63   115 
Male   118   109   227 
Region of Enrollment 
[Units: Participants]
     
United States   170   172   342 


  Outcome Measures

1.  Primary:   Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description   [ Time Frame: 1 year ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01456000     History of Changes
Other Study ID Numbers: 25-3002
Study First Received: October 17, 2011
Results First Received: April 18, 2016
Last Updated: July 25, 2016
Health Authority: United States: Food and Drug Administration