Status:
TERMINATED
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
Lead Sponsor:
nContact Surgical Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat pa...
Detailed Description
The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillat...
Eligibility Criteria
Inclusion
- Age \> 18 years; \< 80 years
- 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
- Left atrial size \> 6.0 cm (pre-op TTE - parasternal 4 chamber view)
- 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).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00950092
Start Date
October 1 2009
End Date
October 1 2013
Last Update
April 3 2014
Active Locations (2)
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1
Venice Regional Medical Center
Venice, Florida, United States, 34285-3298
2
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120