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A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation (Stop-AF)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT00523978
First received: August 31, 2007
Last updated: July 25, 2012
Last verified: July 2012
Results First Received: April 10, 2012  
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: Arctic Front® Cryoablation Catheter
Drug: Flecainide or Sotalol or Propafenone

  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
Investigators at 26 sites in the United States and Canada, enrolled and randomized a total of 245 study subjects, during the 21 months trial period, between 10 October 2006 and 30 June 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cryoablation an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
Standard Treatment With Drugs Only a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.

Participant Flow:   Overall Study
    Cryoablation     Standard Treatment With Drugs Only  
STARTED     171     87  
COMPLETED     162     79  
NOT COMPLETED     9     8  
Withdrawal by Subject                 3                 7  
Screen Failures                 5                 1  
Death                 1                 0  



  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
Cryoablation an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
Standard Treatment With Drugs Only a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
Total Total of all reporting groups

Baseline Measures
    Cryoablation     Standard Treatment With Drugs Only     Total  
Number of Participants  
[units: participants]
  163     82     245  
Age  
[units: years]
Mean ± Standard Deviation
  56.7  ± 0.73     56.4  ± 1.04     56.6  ± 0.6  
Gender  
[units: participants]
     
Female     38     18     56  
Male     125     64     189  
Region of Enrollment  
[units: participants]
     
United States     123     63     186  
Canada     40     19     59  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Acute Procedural Success (APS)   [ Time Frame: 371.4 Minutes (Average) ]

2.  Primary:   Freedom From Chronic Treatment Failure (CTF)   [ Time Frame: 12 month follow up period ]

3.  Primary:   Treatment Success   [ Time Frame: 12 months ]

4.  Primary:   Freedom From Major Atrial Fibrillation Events (MAFEs)   [ Time Frame: 12 Months ]

5.  Primary:   Cryoablation Procedure Events (CPEs)   [ Time Frame: To end of ablation procedure ]


  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 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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linda Nelson, RN, BSN, MBA - AF Solutions Clinical Operations Director
Organization: Medtronic AF Solutions
phone: (763)526-2891
e-mail: linda.k.nelson@medtronic.com


No publications provided by Medtronic Atrial Fibrillation Solutions

Publications automatically indexed to this study:

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT00523978     History of Changes
Other Study ID Numbers: PS-023
Study First Received: August 31, 2007
Results First Received: April 10, 2012
Last Updated: July 25, 2012
Health Authority: United States: Food and Drug Administration