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

This study is currently recruiting participants.
Verified February 2013 by Biosense Webster, Inc.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01639495
First received: July 10, 2012
Last updated: February 22, 2013
Last verified: February 2013
History of Changes

July 10, 2012
February 22, 2013
July 2012
July 2014   (final data collection date for primary outcome measure)
Freedom from atrial tachyarrhythmias [ Time Frame: Day 91-361 ] [ Designated as safety issue: Yes ]
Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as "atrial tachyarrhythmias") based on electrocardiographic data during the effectiveness evaluation period (Day 91-361).
Same as current
Complete list of historical versions of study NCT01639495 on ClinicalTrials.gov Archive Site
  • Acute Success [ Time Frame: End of procedure ] [ Designated as safety issue: No ]
  • Peri-procedural SAEs [ Time Frame: Less than or equal to 30 days post procedure ] [ Designated as safety issue: Yes ]
  • Late onset SAEs [ Time Frame: Greater than 30 days post procedure ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.

The device is currently under investigation with IDE #G110030. This continued access study will enroll subjects that have participated in the Smart-AF IDE study. Subjects with drug refractory symptomatic paroxysmal atrial fibrillation (PAF) will be considered for this study. Effectiveness and safety endpoints have been defined and will be evaluated post treatment.
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Device: THERMOCOOL® SMARTTOUCH™ Catheter
AF Ablation
Experimental: THERMOCOOL® SMARTTOUCH™ Catheter
Intervention: Device: THERMOCOOL® SMARTTOUCH™ Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
148
January 2015
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have had at least 3 atrial fibrillation episodes within 6 months of this study
  • Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
  • 18 years of age or older

Exclusion Criteria including, but not limited to:

  • Have had previous ablation for atrial fibrillation
  • Have take amiodarone within 6 months of this study
  • Have had any heart surgery within the last 60 days
  • Have had a heart attack within the last 60 days
  • Females who are pregnant or breast feeding
Both
18 Years and older
No
Contact: Robert Stagg (909) 839-8611 rstagg@its.jnj.com
Contact: Allison Rice (909) 839-7320 arice5@its.jnj.com
United States
 
NCT01639495
SMART-AF CA
No
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Not Provided
Biosense Webster, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP