Clinical trial NCT01639495: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
Official title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation Continued Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Keywords: Drug refractory
Atrial fibrillation
Antiarrhythmic drug failure
Atrial tachyarrhythmias
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-12
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study had a single arm: catheter ablation for PAF
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias
timeFrame: Day 91-361
measure: Incidence of Primary Adverse Events Within Specified Study Period
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Peri-procedural Serious Adverse Events
timeFrame: Within 8-30 days post procedure
measure: Percentage of Subjects Achieved Acute Effectiveness
timeFrame: 5 hours of procedure time
measure: Late Onset Serious Adverse Events
timeFrame: From 31 days post procedure to month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Hospitals
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennslyvania
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Foundation
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References: