Phase 3
Completed N=148
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation CONTINUED ACCESS
Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation
Source: ClinicalTrials.gov NCT01639495 ↗
Enrolled (actual)
148
Serious AEs
31.9%
Results posted
May 2018
Primary outcomePrimary: Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias — 60.6; 60.8; 60 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a prospective, multicenter, non-randomized continued access clinical evaluation utilizing the THERMOCOOL® SMARTTOUCH™ catheter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias |
60.6; 60.8; 60 | — |
| PRIMARY Incidence of Primary Adverse Events Within Specified Study Period |
17.4; 13.7; 26.2 | — |
| SECONDARY Peri-procedural Serious Adverse Events |
2; 2; 1 | — |
| SECONDARY Percentage of Subjects Achieved Acute Effectiveness |
97.2 | — |
| SECONDARY Late Onset Serious Adverse Events |
27; 1; 26 | — |
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
Data sourced from ClinicalTrials.gov (NCT01639495). 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.