Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs (ENABLE)

This study has been terminated.
(Study terminated based on decision of Sponsor.)
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT00477230
First received: May 21, 2007
Last updated: June 26, 2012
Last verified: June 2012
Results First Received: June 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Device: Endoscopic Ablation System
Drug: Standard Anti-arrhythmic Drug (AAD) Therapy

  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
The study was terminated early by the decision of the Sponsor after 64 participants were enrolled and 25 were treated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None outside of the protocol.

Reporting Groups
  Description
Single Ablation Procedure With Endoscopic Ablation System Single ablation procedure with Endoscopic Ablation System
Standard Anti-arrhythmic Drug Therapy Medication as prescribed by physician.

Participant Flow:   Overall Study
    Single Ablation Procedure With Endoscopic Ablation System     Standard Anti-arrhythmic Drug Therapy  
STARTED     32     32  
COMPLETED     12     1  
NOT COMPLETED     20     31  



  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
Single Ablation Procedure With Endoscopic Ablation System Single ablation procedure with Endoscopic Ablation System
Standard Anti-arrhythmic Drug Therapy Medication as prescribed by physician.
Total Total of all reporting groups

Baseline Measures
    Single Ablation Procedure With Endoscopic Ablation System     Standard Anti-arrhythmic Drug Therapy     Total  
Number of Participants  
[units: participants]
  32     32     64  
Age, Customized  
[units: Participants]
     
Less than 18 Years     0     0     0  
Greater than or equal to 18 Years     32     32     64  
Gender, Customized  
[units: Participants]
     
Male     0     0     0  
Female     0     0     0  
Unknown     32     32     64  
Region of Enrollment  
[units: participants]
     
United States     32     32     64  



  Outcome Measures

1.  Primary:   Freedom for Symptomatic Episode of Atrial Fibrillation at One Year   [ Time Frame: One Year ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
This study was terminated early due to Sponsor decision. Therefore, full patient assignement to treatments post-randomziation did not occur. Results and other measures cannot be determined because most patients exited the study before completion.  


Results Point of Contact:  
Name/Title: Burke T. Barrett, Study Director
Organization: CardioFocus, Inc.
phone: 508 658-7200
e-mail: bbarrett@cardiofocus.com


No publications provided


Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT00477230     History of Changes
Other Study ID Numbers: ENABLE 25-2064
Study First Received: May 21, 2007
Results First Received: June 26, 2012
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration