Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)

Study Overview
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Brief Summary
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The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.

Official Title
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Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI) for Endocardial Ablation of Patients With Persistent Atrial Fibrillation (LME-167)

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Endocardial Ablation Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Signed the Patient Informed Consent Form (ICF) Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF ≥ 7 days) Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD. Able and willing to comply with all pre-, post-, and follow-up testing and requirements. Exclusion Criteria: Previous surgical or catheter ablation for atrial fibrillation Current condition of continuous AF > 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF Any carotid stenting or endarterectomy Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. LA size > 55 mm LVEF <40% AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Significant pulmonary disease (i.e. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms Uncontrolled heart failure or NYHA function class III and IV MI within the past 2 months Any cardiac surgery (i.e. CABG) within the past 2 months Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) Awaiting cardiac transplantation or other cardiac surgery within the next 12 months Documented thromboembolic event (including TIA) within the past 12 months Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study Active illness or active systemic infection or sepsis Unstable angina History of blood clotting or bleeding abnormalities Contraindication to anticoagulation (eg, heparin or warfarin) Life expectancy less than 12 months Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation Presence of a condition that precludes vascular access Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation Currently enrolled in another device, biologics, or drug study Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Endocardial Ablation Procedure<br>ablation with Linear type catheter | Device: Endocardial Ablation Procedure<br> <br> * Other names: Linear Ablation Connection Cable (M-5948-01-I);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Onset of Primary Adverse Events | Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events | Within 7 days | 
| Confirmation of entrance block | Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification) | Intraoperative | 
| Confirmation of bi-directional block | Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Device Effects (SADEs) | Incidence of Serious Adverse Device Effects (SADEs) during follow-up | 1 Year | 
| Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia | Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure | 3, 6 and 12 months post-procedure |