Phase 3 N=81 Treatment

Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF

Paroxysmal Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT00958165 ↗

Enrolled (actual)

Serious AEs

13.9%

Results posted

Jul 2016

Primary outcome: 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 Successful participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: CardioFocus EAS-AC (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: CardioFocus
Primary completion: Mar 2012

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	—

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).

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

View full record on ClinicalTrials.gov →

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.