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THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS

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ClinicalTrials.gov Identifier: NCT01639495
Recruitment Status : Completed
First Posted : July 12, 2012
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Intervention: Device: THERMOCOOL® SMARTTOUCH™ Catheter

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled 148 subjects at 15 clinical sites in the U.S. over the course of approximately 8 months. The first subject was enrolled on July 26, 2012, and the last subject was enrolled on March 18, 2013. The study’s last index ablation procedure was on April 24, 2013.

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
THERMOCOOL® SMARTTOUCH™ Catheter THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation

Participant Flow:   Overall Study
    THERMOCOOL® SMARTTOUCH™ Catheter
STARTED   148 [1] 
Safety Cohort [2]   144 
Primary Effectiveness Cohort [3]   138 
COMPLETED   132 
NOT COMPLETED   16 
Lost to Follow-up                6 
Consented but didn’t have study catheter                4 
Not meeting inclusion/exclusion criteria                4 
No radiofrequency energy applied                2 
[1] Patients who signed the informed consent.
[2] Safety population includes those enrolled subjects who underwent insertion of the study catheter.
[3] Safety cohort subjects meeting eligibility criteria & receiving radiofrequency (RF) ablation for AF



  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.
All subjects who signed informed consent.

Reporting Groups
  Description
THERMOCOOL® SMARTTOUCH™ Catheter THERMOCOOL® SMARTTOUCH™ Catheter: Catheter Ablation for Atrial Fibrillation

Baseline Measures
   THERMOCOOL® SMARTTOUCH™ Catheter 
Overall Participants Analyzed 
[Units: Participants]
 148 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.1  (10.36) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      43  29.1% 
Male      105  70.9% 
[1] All subjects who signed informed consent.
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2   1.4% 
Not Hispanic or Latino      146  98.6% 
Unknown or Not Reported      0   0.0% 
[1] All subjects who signed informed consent.
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   0.7% 
White      147  99.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   148 


  Outcome Measures

1.  Primary:   Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias   [ Time Frame: Day 91-361 ]

2.  Primary:   Incidence of Primary Adverse Events Within Specified Study Period   [ Time Frame: 12 months post procedure ]

3.  Secondary:   Peri-procedural Serious Adverse Events   [ Time Frame: Within 8-30 days post procedure ]

4.  Secondary:   Percentage of Subjects Achieved Acute Effectiveness   [ Time Frame: 5 hours of procedure time ]

5.  Secondary:   Late Onset Serious Adverse Events   [ Time Frame: From 31 days post procedure to month 12 ]


  Serious Adverse Events


  Other Adverse Events


  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

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: Robert Stagg, PhD, Manager, Clinical Franchise
Organization: Biosense Webster, Inc.
phone: (949) 450-7779
e-mail: rstagg@its.jnj.com



Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01639495     History of Changes
Other Study ID Numbers: SMART-AF CA
First Submitted: July 10, 2012
First Posted: July 12, 2012
Results First Submitted: September 29, 2017
Results First Posted: May 15, 2018
Last Update Posted: May 15, 2018