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Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation (En-GARDE)

This study has been terminated.
(Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.)
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01057394
First received: January 26, 2010
Last updated: July 27, 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: Endoscopically guided PVI Ablation
Device: RF PVI 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Sponsor stopped the study for business reasons before any participants were enrolled in the RF arm.

Reporting Groups
  Description
Radiofrequency Ablation Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
Visually Guided Ablation Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation

Participant Flow:   Overall Study
    Radiofrequency Ablation   Visually Guided Ablation
STARTED   0   21 [1] 
COMPLETED   0   19 [2] 
NOT COMPLETED   0   2 
Not eligible                0                2 
[1] 21 enrolled participants
[2] 19 treated participants



  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.
No text entered.

Reporting Groups
  Description
Visually Guided Ablation Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation

Baseline Measures
   Visually Guided Ablation 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Mean (Standard Deviation)
 59  (8) 
Gender 
[Units: Participants]
 
Female   9 
Male   12 
Region of Enrollment 
[Units: Participants]
 
Czech Republic   16 
Italy   5 


  Outcome Measures

1.  Primary:   Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation   [ Time Frame: 3 Months ]


  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: NCT01057394     History of Changes
Other Study ID Numbers: 25-2758
Study First Received: January 26, 2010
Results First Received: April 18, 2016
Last Updated: July 27, 2016
Health Authority: Europe: Post-market study