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

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. Identifier: NCT01639495
Recruitment Status : Completed
First Posted : July 12, 2012
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
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
Official Title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
Actual Study Start Date : July 1, 2012
Actual Primary Completion Date : June 1, 2014
Actual Study Completion Date : October 1, 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
AF Ablation

Primary Outcome Measures :
  1. 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

  2. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 identifier (NCT number): NCT01639495

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Sponsors and Collaborators
Biosense Webster, Inc.

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Responsible Party: Biosense Webster, Inc. Identifier: NCT01639495     History of Changes
Other Study ID Numbers: SMART-AF CA
First Posted: July 12, 2012    Key Record Dates
Results First Posted: May 15, 2018
Last Update Posted: May 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Biosense Webster, Inc.:
Drug refractory
Atrial fibrillation
Antiarrhythmic drug failure
Atrial tachyarrhythmias
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes