Continued Access Protocol (CAP-AF)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT00889681
First received: April 24, 2009
Last updated: March 26, 2014
Last verified: March 2014
Results First Received: February 3, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Intervention: Device: Arctic Front Cardiac Cryoablation System

  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 ten (10) sites enrolled a total of 81 study subjects between March 31, 2009 and January 24, 2011. The first subject was cryoablated on April 3, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were three (3) subjects who were early exits in the study, two for not meeting qualification criteria and one for insurance disapproval.

Reporting Groups
  Description
Enrolled for Cryoablation Treatment All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.

Participant Flow:   Overall Study
    Enrolled for Cryoablation Treatment  
STARTED     81  
Received Treatment     78  
COMPLETED     78  
NOT COMPLETED     3  
Not meeting qualification Criteria                 2  
Insurance disapproval                 1  



  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.
All enrolled subjects

Reporting Groups
  Description
Enrolled for Cryoablation Treatment All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation.

Baseline Measures
    Enrolled for Cryoablation Treatment  
Number of Participants  
[units: participants]
  81  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     56  
>=65 years     25  
Age  
[units: years]
Mean ± Standard Deviation
  58.7  ± 10.4  
Gender  
[units: participants]
 
Female     22  
Male     59  
Region of Enrollment  
[units: participants]
 
United States     81  



  Outcome Measures
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1.  Primary:   Cryoablation Procedure Events (CPEs)   [ Time Frame: 365 days ]

2.  Primary:   Acute Procedural Success (APS)   [ Time Frame: At the conclusion of the cryoablation procedure ]

3.  Primary:   Freedom From Major Atrial Fibrillation Events (MAFE)   [ Time Frame: 365 days ]

4.  Primary:   Long-term Clinical Success   [ Time Frame: 180 days ]


  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: Dana Wigert- Sr. Clinical Research Specialist
Organization: Medtronic- AF Solutions
phone: 763-526-2802
e-mail: dana.wigert@medtronic.com


No publications provided


Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT00889681     History of Changes
Other Study ID Numbers: CAP PS-024
Study First Received: April 24, 2009
Results First Received: February 3, 2014
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration