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OpenTrials
Completed

NCT Number: NCT00971204

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

This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

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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 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 to 70 years
  • paroxysmal atrial fibrillation
  • failure of at least one AAD
  • others

Exclusion criteria

  • overall good health as established by multiple criteria

Treatment and study plan

CardioFocus HeartLight Endoscopic Ablation System

Device

PVI ablation

Primary outcomes

  1. Freedom From Recurrence of Atrial Fibrillation

    Time frame: 12 months

    Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.

Sponsors and collaborators

Lead sponsor

CardioFocus

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 3, 2009
Registry last updated
Aug 1, 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.

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