CompletedPhase 3

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

172 participantsStarted 2011-06

Plain-language summary

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.

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: * 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

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

Timeframe: 12-months

Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.

Timeframe: 7 days of the AF ablation procedure

Trial details

NCT IDNCT01385202

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-02

Results submitted2014-12-17

View on ClinicalTrials.gov More Heart Diseases trials