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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01385202
First Posted: June 30, 2011
Last Update Posted: January 26, 2015
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.
Information provided by (Responsible Party):
Biosense Webster, Inc.
June 27, 2011
June 30, 2011
December 17, 2014
January 26, 2015
January 26, 2015
June 2011
February 2013   (Final data collection date for primary outcome measure)
  • 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).
  • 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.
  • Freedom 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).
  • Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. [ Time Frame: 7 days of the AF ablation procedure ]
    The primary safety endpoint will be the incidence of early onset (within 7 days of the AF ablation procedure) primary adverse events.
Complete list of historical versions of study NCT01385202 on ClinicalTrials.gov Archive Site
Rate of Acute Success [ Time Frame: End of procedure ]
Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).
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: None (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
Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.

*   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
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
 
 
NCT01385202
Smart-AF
Not Provided
Not Provided
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.
January 2015

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