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Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation (MAGELLAN)

This study has been terminated.
(Business reasons)
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00741611
First received: August 25, 2008
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
Results First Received: August 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Paroxysmal Atrial Fibrillation
Interventions: Device: HD Mesh Ablation System
Drug: Anti-arrhythmic drugs

  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
Between July 2008 and November 2009, 44 patients were enrolled into the study. The study Sponsor made a business decision in late November 2009 to terminate the trial early; enrollment was closed at that time.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 44 enrolled patients, a total of 36 patients were treated. Treated patients were followed for 12 months.

Reporting Groups
  Description
Mesh Ablation with HD Mesh Ablation System; energy delivered to the heart tissue intended to disrupt the abnormal electrical pathways which cause atrial fibrillation to occur.
Drug Treatment with anti-arrhythmic drugs: treatment was selected by the Investigator and administered in accordance with the approved drug labeling using labeled doses for the atrial fibrillation indication. Per protocol, medications were limited to sotalol, flecainide, propafenone, dofetilide, and amiodarone and did not include rate control medications or calcium chanel blockers.
Roll-ins Investigator's first patients treated with the experimental mesh ablation system prior to the start of the study randomization.

Participant Flow:   Overall Study
    Mesh     Drug     Roll-ins  
STARTED     4     3     29  
COMPLETED     4     1     26  
NOT COMPLETED     0     2     3  
Death                 0                 0                 1  
Withdrawal by Subject                 0                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Mesh Ablation with HD Mesh Ablation System
Drug Treatment with anti-arrhythmic drugs
Roll-ins Investigator's first patients treated with mesh prior to the start of the study randomization.
Total Total of all reporting groups

Baseline Measures
    Mesh     Drug     Roll-ins     Total  
Number of Participants  
[units: participants]
 		  4     3     29     36  
Age  
[units: years]
Mean ± Standard Deviation 		  64.8  ± 6.18     66.0  ± 9.54     60.2  ± 9.68     61.2  ± 9.36  
Gender  
[units: participants]
 		       
Female     2     0     9     11  
Male     2     3     20     25  
Region of Enrollment  
[units: participants]
 		       
United States     4     3     29     36  



  Outcome Measures
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1.  Primary:   Number of Participants With Major Complications   [ Time Frame: 12 months ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Serious Atrial Fibrillation Events   [ Time Frame: 12 months ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants With Freedom From Symptomatic Atrial Fibrillation   [ Time Frame: 12 months ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With the Occurrence of Pulmonary Vein Stenosis in Mesh Treated Patients.   [ Time Frame: 12 months ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Acute Procedural Success in Mesh Treated Patients.   [ Time Frame: During the mesh ablation procedure ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
Due to the study’s early termination and enrollment of only 7 randomized patients, predefined study endpoints were not evaluable. Treated patients were followed through 12 months postprocedure and data were summarized where possible.  


Results Point of Contact:  
Name/Title: Anne Marie Harcarik
Organization: CR Bard
phone: 908-277-8051
e-mail: annemarie.harcarik@crbard.com


No publications provided


Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00741611     History of Changes
Other Study ID Numbers: BEP-4408-2007, IDE # G070179
Study First Received: August 25, 2008
Results First Received: August 27, 2012
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration