Back to resultsPost-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Endoscopically Guided Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- Centro Cardiologico Monzino
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HeartLight Ablation
Arm Description
Outcomes
Primary Outcome Measures
Acute Isolation of Pulmonary Veins.
99% of pulmonary veins were isolated (72/73)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01196923
Brief Title
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioFocus
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HeartLight Ablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endoscopically Guided Ablation
Intervention Description
Visually Guided Ablation using EAS-AC
Primary Outcome Measure Information:
Title
Acute Isolation of Pulmonary Veins.
Description
99% of pulmonary veins were isolated (72/73)
Time Frame
Acute PVI measured on the day of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burke Barrett
Organizational Affiliation
CardioFocus
Official's Role
Study Director
Facility Information:
Facility Name
Centro Cardiologico Monzino
City
Milan
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
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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