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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.
Sponsor:
Information provided by (Responsible Party):
CardioFocus
ClinicalTrials.gov Identifier:
NCT01196923
First received: September 7, 2010
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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: Allocation: Non-Randomized
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:

U.S. FDA Resources

Further study details as provided by CardioFocus:

Primary Outcome Measures:
  • To determine the EAS-AC treatment success rate defined as the freedom from documented atrial fibrillation symptoms during the 12-month evaluation period. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Device: Endoscopically Guided Ablation
    Visually Guided Ablation using EAS-AC
  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
  • 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: NCT01196923

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

No publications provided

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01196923     History of Changes
Other Study ID Numbers: 25-2858
Study First Received: September 7, 2010
Last Updated: June 19, 2012
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on June 13, 2013