We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 27 for:    contact AFL
Previous Study | Return to List | Next Study

Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System (CONTACT_AFL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401361
First Posted: July 25, 2011
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
Results First Submitted: November 4, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Typical Atrial Flutter
Intervention: Device: Treatment Arm

  Participant Flow
  Hide Participant Flow

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[1] 16 subjects were withdrawn prior to the use of the investigational device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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: Nancy Ouch
Organization: St. Jude Medical
phone: +19497695041
e-mail: NOuch@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01401361     History of Changes
Other Study ID Numbers: 90064772
First Submitted: July 21, 2011
First Posted: July 25, 2011
Results First Submitted: November 4, 2013
Results First Posted: December 23, 2013
Last Update Posted: October 25, 2016