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

Phase 3

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: CardioFocus EAS-AC

• Registration Number: NCT00958165
• Lead Sponsor: CardioFocus

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Results First Submitted: 2016-04-18
• Results First Submitted QC: 2016-06-16
• Status Verified: 2016-07
• Results First Posted: 2016-07-27
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EAS-AC	CardioFocus EAS-AC	PVI with EAS-AC

Primary Outcome Measures

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

Trial Locations

Locations (3)

St. Georg Hosptial; 🇩🇪 Hamburg, Germany

Cardioangiologisches Centrum Bethanien - CCB; 🇩🇪 Frankfurg, Germany

Universität Leipzig - Herzzentrum; 🇩🇪 Leipzig, Germany