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

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.
 
ClinicalTrials.gov Identifier: NCT01385202
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Study Description
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Brief Summary:
The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.

Condition or disease Intervention/treatment Phase
Heart Diseases Arrhythmia Atrial Fibrillation Device: THERMOCOOL® SMARTTOUCH™ Catheter Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: N/A
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
Study Start Date : June 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: THERMOCOOL® SMARTTOUCH™ Catheter Device: THERMOCOOL® SMARTTOUCH™ Catheter
AF Ablation


Outcome Measures
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Primary Outcome Measures :
  1. The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up [ Time Frame: 12-months ]
    The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).

  2. Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. [ Time Frame: 7 days of the AF ablation procedure ]
    Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.


Secondary Outcome Measures :
  1. Rate of Acute Success [ Time Frame: End of procedure ]
    Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).


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

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:

  • 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
Contacts and Locations
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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): NCT01385202


Locations
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Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
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Study Chair: Andrea Natale, MD Texas Cardiac Arrhythmia Research
Study Chair: David J Wilber, MD Loyola University
Study Chair: Francis E Marchlinski, MD University of Pennsylvania
Study Chair: Douglas L Packer, MD Mayo Clinic
Study Chair: Hiroshi Nakagawa, MD, Ph.D. University of Oklahoma
Study Chair: Hans Kottkamp, MD University Leipzig
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01385202    
Other Study ID Numbers: Smart-AF
First Posted: June 30, 2011    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015
Last Verified: January 2015
Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes