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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01385202
First received: June 27, 2011
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Heart Diseases
Arrhythmia
Atrial Fibrillation
 Device: THERMOCOOL® SMARTTOUCH™ Catheter
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 172
Study Start Date: June 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THERMOCOOL® SMARTTOUCH™ Catheter Device: THERMOCOOL® SMARTTOUCH™ Catheter
AF Ablation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385202

  Show 23 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
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

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01385202     History of Changes
Other Study ID Numbers: Smart-AF
Study First Received: June 27, 2011
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation

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

ClinicalTrials.gov processed this record on May 23, 2013