Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
NCT ID: NCT01103661
Last Updated: 2014-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2010-04-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Numeris-AF Guided Coagulation System
Numeris®-AF Guided Coagulation System with VisiTrax®
Combined epicardial / endocardial procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially.
Interventions
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Numeris®-AF Guided Coagulation System with VisiTrax®
Combined epicardial / endocardial procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially.
Eligibility Criteria
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Inclusion Criteria
* Left atrium less than or equal to 6.5 cm (TTE)
* History of AF for less than or equal to 10 years
* Provided written informed consent
* Symptomatic longstanding persistent Atrial Fibrillation (AF).
Exclusion Criteria
* Left ventricular ejection fraction \< 30%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* Measured left ventricular wall thickness \> 1.5 cm
* History of coagulopathy
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA), excluding fully resolved TIA
* Patients who have active infection or sepsis
* Patients who have uncorrected reversible cause(s) of AF
* Patients who are contraindicated for anticoagulants
* Patients who are being treated for arrhythmias other than AF
* Patients who have had any previous AF or left atrial catheter ablation
* Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
* Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
18 Years
80 Years
ALL
No
Sponsors
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nContact Surgical Inc.
INDUSTRY
Responsible Party
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Locations
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The Care Group, St Vincent Hospital
Indianapolis, Indiana, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Texas Cardiac Arrhythmia Institute, St. David's Hospital
Austin, Texas, United States
Cardiothoracic Surgical Associates, CJW Medical Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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VAL-1140
Identifier Type: -
Identifier Source: org_study_id
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