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

This study has been completed.
Information provided by (Responsible Party):
CardioFocus Identifier:
First received: August 12, 2009
Last updated: July 27, 2016
Last verified: July 2016
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).

Condition Intervention Phase
Paroxysmal Atrial Fibrillation Device: CardioFocus EAS-AC Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: August 2009
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EAS-AC
Device: CardioFocus EAS-AC


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00958165

Cardioangiologisches Centrum Bethanien - CCB
Frankfurg, Germany, 60431
St. Georg Hosptial
Hamburg, Germany, 20099
Universität Leipzig - Herzzentrum
Leipzig, Germany, 04289
Sponsors and Collaborators
  More Information

Responsible Party: CardioFocus Identifier: NCT00958165     History of Changes
Other Study ID Numbers: 25-2738
Study First Received: August 12, 2009
Results First Received: April 18, 2016
Last Updated: July 27, 2016

Keywords provided by CardioFocus:
Treatment of PAF using EAS-AC

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on June 22, 2017