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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
Last Update Posted : January 9, 2015
Information provided by (Responsible Party):
Biosense Webster, Inc.

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

Condition or disease Intervention/treatment Phase
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation Device: THERMOCOOL® SMARTTOUCH™ Catheter Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
Study Start Date : July 2012
Primary Completion Date : June 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
AF Ablation

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Acute Success [ Time Frame: End of procedure ]
  2. Peri-procedural SAEs [ Time Frame: Less than or equal to 30 days post procedure ]
  3. Late onset SAEs [ Time Frame: Greater than 30 days post procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639495

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Sponsors and Collaborators
Biosense Webster, Inc.

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01639495     History of Changes
Other Study ID Numbers: SMART-AF CA
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Biosense Webster, Inc.:
Drug refractory
Atrial fibrillation
Antiarrhythmic drug failure
Atrial tachyarrhythmias

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes