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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.

July 10, 2012
July 12, 2012
September 29, 2017
May 15, 2018
May 15, 2018
July 1, 2012
June 1, 2014   (Final data collection date for primary outcome measure)
  • Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias [ Time Frame: Day 91-361 ]
    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). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures
  • Incidence of Primary Adverse Events Within Specified Study Period [ Time Frame: 12 months post procedure ]
    Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.
Freedom from atrial tachyarrhythmias [ Time Frame: Day 91-361 ]
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).
Complete list of historical versions of study NCT01639495 on ClinicalTrials.gov Archive Site
  • Peri-procedural Serious Adverse Events [ Time Frame: Within 8-30 days post procedure ]
    Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure
  • Percentage of Subjects Achieved Acute Effectiveness [ Time Frame: 5 hours of procedure time ]
    Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins
  • Late Onset Serious Adverse Events [ Time Frame: From 31 days post procedure to month 12 ]
    Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure
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
Intervention Model: Single Group Assignment
Intervention Model Description:
This study had a single arm: catheter ablation for PAF
Masking: None (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.
 
Completed
148
Same as current
October 1, 2014
June 1, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01639495
SMART-AF CA
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Plan to Share IPD: Undecided
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
Not Provided
Biosense Webster, Inc.
April 2018

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