Phase 3
Completed N=81
Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
Source: ClinicalTrials.gov NCT00958165 ↗Enrolled (actual)
81
Serious AEs
13.9%
Results posted
Jul 2016
Primary outcomePrimary: Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period. — 42 Successful 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 This can indicate results are unpublished — a known publication-bias signal.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
The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period. |
42 | — |
Eligibility Criteria
Inclusion Criteria
- Symptomatic, Paroxysmal atrial fibrillation (AF)
- 18 to 70 years of age
- Failure of at least one AAD
- Others
Exclusion Criteria
- Generally good overall health as determined by multiple criteria
- Willing to participate in a study
- Others
Data sourced from ClinicalTrials.gov (NCT00958165). 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.