Trial record 1 of 14 for:    contact AFL
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Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter (CONTACT AFL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01401361
First received: July 21, 2011
Last updated: March 12, 2014
Last verified: March 2014
Results First Received: November 4, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Typical Atrial Flutter
Intervention: Device: Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact 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
No text entered.

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
Treatment Arm Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .

Participant Flow:   Overall Study
    Treatment Arm  
STARTED     150  
COMPLETED     122 [1]
NOT COMPLETED     28  
Withdrawal by Subject                 16  
Lack of Efficacy                 6  
Physician Decision                 1  
Lost to Follow-up                 3  
Subject/family decision post procedure                 2  
[1] 16 subjects were withdrawn prior to the use of the investigational device



  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
Treatment Arm Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .

Baseline Measures
    Treatment Arm  
Number of Participants  
[units: participants]
  150  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     68  
>=65 years     82  
Age  
[units: years]
Mean ± Standard Deviation
  64.82  ± 11.97  
Gender  
[units: participants]
 
Female     25  
Male     125  
Region of Enrollment  
[units: participants]
 
United States     140  
Canada     10  



  Outcome Measures
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1.  Primary:   Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure   [ Time Frame: 7 days ]

2.  Primary:   Primary Efficacy   [ Time Frame: 30 minutes ]

3.  Secondary:   Secondary Efficacy   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: Nancy Ouch
Organization: St. Jude Medical
phone: +19497695041
e-mail: NOuch@sjm.com


No publications provided


Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01401361     History of Changes
Other Study ID Numbers: 90064772
Study First Received: July 21, 2011
Results First Received: November 4, 2013
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration