Atrial Fibrillation
Conditions
Keywords
AF, atrial fibrillation, ablation, surgical ablation, afib, coagulation, RF, epicardial, Arrhythmias
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 patients with persistent and longstanding persistent AF during concomitant cardiac surgery.
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 Fibrillation(AF)during concomitant cardiac surgery.
Interventions
DEVICENumeris-AF Tethered Coagulation System with VisiTrax
Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System
Sponsors
nContact Surgical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure. | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure. | 9 months |
| Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs. | 9 months |
Countries
United States
Outcome results
None listed