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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01385202
First received: June 27, 2011
Last updated: March 19, 2014
Last verified: March 2014

June 27, 2011
March 19, 2014
June 2011
February 2013   (final data collection date for primary outcome measure)
  • Freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    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).
  • Incidence of early onset (within 7 days of the AF ablation procedure) primary adverse events. [ Time Frame: 7 days of the AF ablation procedure ] [ Designated as safety issue: Yes ]
    The primary safety endpoint will be the incidence of early onset (within 7 days of the AF ablation procedure) primary adverse events.
Same as current
Complete list of historical versions of study NCT01385202 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
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

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.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Diseases
  • Arrhythmia
  • 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
172
May 2013
February 2013   (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:

  • 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 information is only displayed when the study is recruiting subjects
United States
 
NCT01385202
Smart-AF
Not Provided
Biosense Webster, Inc.
Biosense Webster, Inc.
Not Provided
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
Biosense Webster, Inc.
March 2014

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