Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Endoscopically Guided Ablation

• Registration Number: NCT01196923
• Lead Sponsor: CardioFocus

Brief Summary

The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of atrial fibrillation.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-07
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2012-03
• Study Completion: 2012-06
• Results First Submitted: 2016-04-18
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-16
• Results First Posted: 2016-07-27
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Symptomatic, Paroxysmal Atrial Fibrillation (AF)
• 18 to 70 Years of age
• 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
HeartLight Ablation	Endoscopically Guided Ablation	-

Primary Outcome Measures

Name	Time	Method
Acute Isolation of Pulmonary Veins.	Acute PVI measured on the day of treatment	99% of pulmonary veins were isolated (72/73)

Trial Locations

Locations (1)

Centro Cardiologico Monzino; 🇮🇹 Milan, Italy