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

This study has been completed.
Information provided by (Responsible Party):
CardioFocus Identifier:
First received: September 7, 2010
Last updated: June 16, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Atrial Fibrillation
Device: Endoscopically Guided Ablation
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Resource links provided by NLM:

Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • Acute Isolation of Pulmonary Veins. [ Time Frame: Acute PVI measured on the day of treatment ] [ Designated as safety issue: No ]
    99% of pulmonary veins were isolated (72/73)

Enrollment: 20
Study Start Date: September 2010
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HeartLight Ablation Device: Endoscopically Guided Ablation
Visually Guided Ablation using EAS-AC


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

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
  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: NCT01196923

Centro Cardiologico Monzino
Milan, Italy
Sponsors and Collaborators
Study Director: Burke Barrett CardioFocus
  More Information

Responsible Party: CardioFocus Identifier: NCT01196923     History of Changes
Other Study ID Numbers: 25-2858 
Study First Received: September 7, 2010
Results First Received: April 18, 2016
Last Updated: June 16, 2016
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on October 25, 2016