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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Cardiologico Monzino

Milan, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopically Guided Ablation

Device

Visually Guided Ablation using EAS-AC

Primary outcomes

Acute Isolation of Pulmonary Veins.

Time frame: Acute PVI measured on the day of treatment

99% of pulmonary veins were isolated (72/73)

Sponsors and collaborators

Lead sponsor

CardioFocus

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Sep 9, 2010
Registry last updated: Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed