nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
NCT ID: NCT00950092
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
5 participants
INTERVENTIONAL
2009-10-31
2013-10-31
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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Treatment
Numeris-AF Tethered Coagulation System with VisiTrax
Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System
Interventions
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Numeris-AF Tethered Coagulation System with VisiTrax
Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Left atrium =\< 6.0 cm
* Documented persistent or longstanding persistent AF
* History of AF =\< 10 years
* Scheduled for a concomitant cardiac procedure
* Coronary bypass surgery (CABG)
* Mitral valve repair/replacement
* Aortic valve replacement
* ASD repair
* Tricuspid valve repair/replacement
* Myxoma
* Any combination of the above procedures
* Provided written informed consent
Exclusion Criteria
* History of AF \> 10 years
* Left ventricular ejection fraction \< 30%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* History of coagulopathy
* Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA)
* Patients who have active infection or sepsis
* Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance
* Patients who are being treated for ventricular arrhythmias
* Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)
* 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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Principal Investigators
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Edward Garrett, M.D.
Role: PRINCIPAL_INVESTIGATOR
Baptist Memorial Hospital - Memphis
Locations
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Venice Regional Medical Center
Venice, Florida, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Countries
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Other Identifiers
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VAL-1116(C)
Identifier Type: -
Identifier Source: org_study_id
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