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Clinical Trials/NCT00958165
NCT00958165CompletedPhase 3

Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation

CardioFocus3 sites in 1 country81 target enrollmentStarted: August 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
81
Locations
3
Primary Endpoint
Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Symptomatic, Paroxysmal atrial fibrillation (AF)
  • •18 to 70 years of age
  • •Failure of at least one AAD

Exclusion Criteria

  • •Generally good overall health as determined by multiple criteria
  • •Willing to participate in a study

Arms & Interventions

EAS-AC

Experimental

PVI with EAS-AC

Intervention: CardioFocus EAS-AC (Device)

Outcomes

Primary Outcomes

Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.

Time Frame: 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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