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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

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ClinicalTrials.gov Identifier: NCT01196923
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : July 27, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
CardioFocus

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Device: Endoscopically Guided Ablation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HeartLight Ablation Device: Endoscopically Guided Ablation
Visually Guided Ablation using EAS-AC




Primary Outcome Measures :
  1. Acute Isolation of Pulmonary Veins. [ Time Frame: Acute PVI measured on the day of treatment ]
    99% of pulmonary veins were isolated (72/73)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196923


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

Responsible Party: CardioFocus
ClinicalTrials.gov Identifier: NCT01196923     History of Changes
Other Study ID Numbers: 25-2858
First Posted: September 9, 2010    Key Record Dates
Results First Posted: July 27, 2016
Last Update Posted: July 27, 2016
Last Verified: June 2016

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