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

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).

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation 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 3

Primary location

Cardioangiologisches Centrum Bethanien - CCB, Frankfurg, Germany

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
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

Treatment and study plan

CardioFocus EAS-AC

Device

PVI for PAF

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

Sponsors and collaborators

Lead sponsor

CardioFocus

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Aug 13, 2009
Registry last updated: Aug 30, 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