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

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.
ClinicalTrials.gov Identifier: NCT01057394
Recruitment Status : Terminated (Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.)
First Posted : January 27, 2010
Results First Posted : August 1, 2016
Last Update Posted : August 1, 2016
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Paroxysmal Atrial Fibrillation
Interventions: Device: Endoscopically guided PVI Ablation
Device: RF PVI 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
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
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 eligible                0                2 
[1] 21 enrolled participants
[2] 19 treated participants

  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
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]
[Units: Years]
Mean (Standard Deviation)
 59  (8) 
[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

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
No text entered.

  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
e-mail: bbarrett@cardiofocus.com

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01057394     History of Changes
Other Study ID Numbers: 25-2758
First Submitted: January 26, 2010
First Posted: January 27, 2010
Results First Submitted: April 18, 2016
Results First Posted: August 1, 2016
Last Update Posted: August 1, 2016