Phase 3
Completed N=172
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov NCT01385202 ↗Enrolled (actual)
172
Serious AEs
23.6%
Results posted
Jan 2015
Primary outcomePrimary: 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 — 70.2 percentage of participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
70.2 | <0.0001 sig |
| PRIMARY Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events. |
9.9 | — |
| SECONDARY Rate of Acute Success |
100; 94.7 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT01385202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.