Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation (SELECT-AF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00926783
First received: June 22, 2009
Last updated: June 5, 2014
Last verified: June 2014
Results First Received: March 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Intervention: Procedure: CFAE ablation

  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 first subject of the study was consented on August 17, 2009. The final follow-up was performed on November 14, 2011. The total study duration was approximately 27 months. A total of 86 subjects were enrolled from 7 participating sites; 2 sites in the United States (US), 4 sites in Canada, and 1 site in Australia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among the 86 consented subjects, two were excluded prior to randomization; one was excluded due to thrombus found on pre-procedure echo. Hence only 83 subjects were randomized to the two treatment arms and underwent radio-frequency ablation

Reporting Groups
  Description
Targeted CFAE Ablation Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
Generalized CFAE Ablation Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.

Participant Flow:   Overall Study
    Targeted CFAE Ablation     Generalized CFAE Ablation  
STARTED     42     41  
COMPLETED     39     38  
NOT COMPLETED     3     3  
Incomplete CFAE Procedures                 3                 3  



  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.
Baseline analysis population is based on enrolled subjects (86) who had demographic information. Four subjects, who didn't have demographic data, were excluded from baseline analysis.

Reporting Groups
  Description
Targeted CFAE Ablation Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
Generalized CFAE Ablation Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
Total Total of all reporting groups

Baseline Measures
    Targeted CFAE Ablation     Generalized CFAE Ablation     Total  
Number of Participants  
[units: participants]
  42     40     82  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 9.8     61.5  ± 9.2     61.6  ± 9.4  
Gender  
[units: participants]
     
Female     13     9     22  
Male     29     31     60  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     37     32     69  
More than one race     0     0     0  
Unknown or Not Reported     5     7     12  
Atrial fibrillation type  
[units: participants]
     
High Burden Paroxysmal     11     19     30  
Persistent     31     21     52  
Duration of Atrial fibrillation diagnosis (Year)  
[units: years]
Mean ± Standard Deviation
  5.8  ± 5.7     5.2  ± 5.2     5.5  ± 5.4  



  Outcome Measures
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1.  Primary:   Proportion of Subjects Who Were Free From Atrial Arrhythmia at One Year.   [ Time Frame: From day 91 to day 365 post first ablation procedure ]

2.  Primary:   Total Radio-frequency (RF) Delivery Time During CFAE   [ Time Frame: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) ]

3.  Secondary:   Duration of Ablation Procedure   [ Time Frame: Duration of ablation procedure (up to about 5 hours) ]

4.  Secondary:   Fluoroscopy Time   [ Time Frame: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) ]

5.  Secondary:   Change in Atrial Fibrillation Cycle Length From Baseline to the End of the Ablation Procedure for Each Target   [ Time Frame: Duration of an Atrial Fibrillation RF ablation procedure (up to 5 hours) ]

6.  Secondary:   Incidence of Atrial Fibrillation (AF) Termination/Regularization   [ Time Frame: Duration of an Atrial Fibrillation RF ablation procedure (up to about 5 hours) ]


  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: Ellen Harris, Sr. Clinical Research Associate, Clinical Operations
Organization: Biosense Webster EMEA
phone: (800) 729-9010
e-mail: eharris@its.jnj.com


No publications provided by Biosense Webster, Inc.

Publications automatically indexed to this study:

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00926783     History of Changes
Other Study ID Numbers: SELECT-AF
Study First Received: June 22, 2009
Results First Received: March 24, 2014
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Australia: Human Research Ethics Committee