ArcticLine Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and effectiveness data on the ArcticLine Catheter.

Official Title
-----------------
ArcticLine Feasibility Study

Conditions
-----------------
Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
-----------------
* Device: ArcticLine Cardiac Cryoablation Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documentation of symptomatic persistent AF: Defined as having a continuous episode that is sustained beyond 7 days documented via consecutive ECG recordings, or Defined as having a continuous episode that is sustained beyond 7 days documented by an ECG recording and one doctor note indicating the patient had symptoms consistent with AF Age 18 through 80 years old Failure or intolerance of at least one Class I or III antiarrhythmic drug Subject is able and willing to consent to participate in the study and will commit to completion of all follow-up requirements Exclusion Criteria: Longstanding persistent AF, defined as continuous AF greater than 12 month duration Left atrial diameter greater than 5.0 cm Active systemic infection History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure Prior left atrial ablation attempt, with exception of: Any pulmonary vein isolation attempt to treat AF, or Successful ablation to treat Wolff-Parkinson White syndrome History of left atrial tachycardia History of cardiac ablation within 90 days of planned clinical study procedure Planned concomitant ventricular ablation Cryoglobulinemia Structural heart disease of clinical significance including: NYHA Class IV Heart Failure Diagnosed with NYHA Class III Heart Failure for more than six months at time of the study ablation procedure LVEF less than 35% Any cardiac surgery (e.g. CABG) within 3 months of the ablation procedure Any mechanical heart valve, prior aortic or tricuspid valve replacement (e.g. valvotomy, valve replacement), or tricuspid valve repair Severe mitral valve regurgitation or stenosis Significant congenital anomaly or anatomy unable to accommodate device Prior surgical maze procedure Unstable angina Myocardial infarction within 3 months of the ablation procedure Presence of primum or secundum atrial septal defect Anomalous pulmonary venous return Prior surgery for congenital heart disease, including atrial septal defect repair Hypertrophic cardiomyopathy with LV septal wall thickness >1.5 cm Uncontrolled hyperthyroidism Thrombocytosis, thrombocytopenia (including history of heparin-induced thrombocytopenia) Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate History of blood clotting or bleeding abnormalities Contraindication to all anticoagulation (e.g. novel oral anticoagulants, heparin or warfarin) Pregnant, nursing or planning to become pregnant during study duration Enrollment in another clinical trial without prior approval from Medtronic Presence or use of left atrial appendage closure device Presence of or planned implantation of a pacemaker, implantable cardiac defibrillator, implantable loop recorder or cardiac resynchronization device with permanent lead placement Pre-existing hemidiaphragmatic paralysis Life expectancy less than one year Known drug or alcohol dependency Existing pulmonary vein stent(s)

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Subjects enrolled and treated with ArcticLine Cardiac Cryoablation Catheter | Device: ArcticLine Cardiac Cryoablation Catheter<br>* Cryoablation<br>* Other names: FlexCath Advance Steerable Sheath;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Primary Safety Events With an Onset Date Within 7 Days Post-procedure. | A primary safety event is defined as: An ArcticLine Catheter-related or ArcticLine cryoablation procedure-related SAE with an onset date within 7 days post-procedure (except as noted below), as adjudicated by the Clinical Events Committee (CEC), described as follows: Atrioesophageal fistula* * Includes atrioesophageal fistula with an onset date at any time after the study cryoablation procedure and is adjudicated by the CEC as either ArcticLine Catheter-related or ArcticLine cryoablation procedure-related. Cardiac perforation/tamponade Cerebrovascular accident Death Esophageal injury Major bleeding Myocardial infarction Pericarditis Phrenic nerve injury (ongoing at hospital discharge) Transient ischemic attack Vagal nerve injury resulting in esophageal dysmotility or gastroparesis Vascular access complications | 7 days |