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Irrigated Ablation System Evaluation for Atrial Fibrillation (AF) (IRASE-AF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01056328
First received: January 22, 2010
Last updated: April 28, 2014
Last verified: April 2014
Results First Received: January 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Paroxysmal Atrial Fibrillation
Interventions: Device: SJM Irrigated Cardiac Ablation System
Device: FDA approved Open Irrigated RF Ablation 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
SJM Cardiac Ablation System SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
FDA Approved Open Irriagated RF Ablation System FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter

Participant Flow:   Overall Study
    SJM Cardiac Ablation System     FDA Approved Open Irriagated RF Ablation System  
STARTED     164     160  
COMPLETED     147     144  
NOT COMPLETED     17     16  



  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.
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Reporting Groups
  Description
SJM Cardiac Ablation System SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
FDA Approved Open Irriagated RF Ablation System FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
Total Total of all reporting groups

Baseline Measures
    SJM Cardiac Ablation System     FDA Approved Open Irriagated RF Ablation System     Total  
Number of Participants  
[units: participants]
  164     160     324  
Age  
[units: years]
Mean ± Standard Deviation
  58.5  ± 12.4     60.6  ± 9.7     59.5  ± 11.2  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     96     96     192  
>=65 years     68     64     132  
Gender  
[units: participants]
     
Female     59     66     125  
Male     105     94     199  
Region of Enrollment  
[units: participants]
     
United States     149     149     298  
Korea, Republic of     9     7     16  
Canada     6     4     10  



  Outcome Measures
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1.  Primary:   Confirmation of Entrance Block in the Pulmonary Veins   [ Time Frame: 20 minutes after initial isolation ]

2.  Primary:   Incidence of Adverse Events Included in the Pre-specified Composite   [ Time Frame: 7 days ]

3.  Primary:   Incidence of Adverse Events Included in the Pre-specified Composite.   [ Time Frame: 12 months ]

4.  Secondary:   Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period   [ Time Frame: 12 months ]

5.  Secondary:   Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs   [ Time Frame: 12 months ]


  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 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.


Results Point of Contact:  
Name/Title: Nicole Glowacki, Clinical Project Manager
Organization: St. Jude Medical
phone: 651-756-3432
e-mail: NGlowacki@sjm.com


No publications provided


Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01056328     History of Changes
Other Study ID Numbers: 90030928
Study First Received: January 22, 2010
Results First Received: January 28, 2014
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration