CompletedPhase 3

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

United States148 participantsStarted 2012-07-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias

Timeframe: Day 91-361

Incidence of Primary Adverse Events Within Specified Study Period

Timeframe: 12 months post procedure

Trial details

NCT IDNCT01639495

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-06-01

Results submitted2017-09-29

View on ClinicalTrials.gov More Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation trials