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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01639495
First received: July 10, 2012
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.


Condition Intervention Phase
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Device: THERMOCOOL® SMARTTOUCH™ Catheter
Phase 3

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Freedom from atrial tachyarrhythmias [ Time Frame: Day 91-361 ] [ Designated as safety issue: Yes ]
    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).


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 ]

Estimated Enrollment: 148
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THERMOCOOL® SMARTTOUCH™ Catheter Device: THERMOCOOL® SMARTTOUCH™ Catheter
AF Ablation

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.

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639495

  Show 20 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01639495     History of Changes
Other Study ID Numbers: SMART-AF CA
Study First Received: July 10, 2012
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
Drug refractory
Atrial fibrillation
Antiarrhythmic drug failure
Atrial tachyarrhythmias

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

ClinicalTrials.gov processed this record on October 02, 2014