- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196923
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
June 16, 2016 updated by: CardioFocus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Milan, Italy
- Centro Cardiologico Monzino
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HeartLight Ablation
|
Visually Guided Ablation using EAS-AC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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Acute PVI measured on the day of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Burke Barrett, CardioFocus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
September 7, 2010
First Submitted That Met QC Criteria
September 8, 2010
First Posted (Estimate)
September 9, 2010
Study Record Updates
Last Update Posted (Estimate)
July 27, 2016
Last Update Submitted That Met QC Criteria
June 16, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-2858
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on Endoscopically Guided Ablation
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University of ManchesterManchester University NHS Foundation TrustWithdrawn
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
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Deutsches Herzzentrum MuenchenCompleted
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Instituto do Cancer do Estado de São PauloAngiodynamics, Inc.Recruiting
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AZ Sint-Jan AVCompletedAtrial FibrillationBelgium