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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT00958165
First received: August 12, 2009
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • Chronic effectiveness in treating PAF. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
PVI with EAS-AC
 Device: CardioFocus EAS-AC
PVI for PAF

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958165

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

No publications provided

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT00958165     History of Changes
Other Study ID Numbers: 25-2738
Study First Received: August 12, 2009
Last Updated: June 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013