nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF

Study Overview
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Brief Summary
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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
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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.

Official Title
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Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Numeris-AF Tethered Coagulation System with VisiTrax


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br> | Device: Numeris-AF Tethered Coagulation System with VisiTrax<br>* Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System<br>* Other names: nContact Surgical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AF, atrial fibrillation, ablation, surgical ablation, afib, coagulation, RF, epicardial, Arrhythmias