IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System

Study Overview
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Brief Summary
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IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.

Detailed Description
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Patients with paroxysmal atrial fibrillation scheduled to undergo cardiac surgery will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.), followed by concomitant cardiac surgery. Subjects will be followed at 7 days, 30 days, 3 months, 6 months and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the index ablation procedure.

Official Title
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IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: IOWA Approach Cardiac Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are ≥ 18 and ≤ 70 years of age on the day of enrollment. Diagnosis of paroxysmal atrial fibrillation defined as symptomatic paroxysmal AF with at least two episodes of paroxysmal AF observed within the 12 months preceding inclusion. Patients are resistant to anti-arrhythmic treatments. Anteroposterior Left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure. Subject has no contraindications to intraoperative transesophageal echocardiography; Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) to be performed including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement Tricuspid valve repair or replacement, or Coronary artery bypass procedures Left ventricular ejection fraction ≥40% as documented by TTE within 12 months prior to the procedure. Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by trial investigators. Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-ups associated with this clinical trial. Exclusion Criteria: Abnormal cardiac and/or epicardial anatomy (such as adhesion, anomalous coronaries, thickened epicardium, etc.) or pericardial reflections on TTE, MRI or CT. Prior left-sided cardiac ablation. Prior history of open chest surgery and/or any procedure where the pericardial space was entered or instrumented (pericardiocentesis, catheter mapping and /or ablation). Patient has a prosthetic heart valve. Patient has a left atrial appendage device Prior history of pericarditis or pericarditis within 3 months based on the TTE examination. Subject is a woman of child bearing age Prior history of rheumatic fever. Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, Atrial septal defect) ASD closure, left atrial appendage occlusion) History of severe chronic gastrointenstinal problems involving the esophagus, stomach and/or untreated acid reflux History of abnormal bleeding and/or clotting disorder. Active malignancy or history of treated cancer within 24 months of enrollment. Clinically significant infection or sepsis. History of stroke or TIA within prior 6 months New York heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment. Body mass index > 35. Estimate glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has ever received dialysis. History of untreated and serious hypotension, bradycardia or chronotropic incompetence. Any of the following within 3 months of enrollment: Major surgery except for the index procedure Myocardial infarction Unstable angina Percutaneous coronary intervention (e.g., CABG or PTCA) Sudden cardiac death event Left atrial thrombus that has not resolved as shown by TEE (transesophageal echo) or CT Implant of pacemaker, ICD (implantable cardioverter defribillator) or CRT (cardiac resynchronization therapy). Solid organ or hematologic transplant, or currently being evaluated for an organ transplant History of pulmonary hypertension with Pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease. Patients with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder). Life expectancy less than one year. Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements. Enrolled in another cardiac clinical trial that would interfere with this trial. Life expectancy less than one year. Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements. Enrolled in another cardiac clinical trial that would interfere with this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: Patients with paroxysmal atrial fibrillation undergoing cardiac surgery and meeting all protocol inclusion/exclusion criteria will be treated with the IOWA Approach Cardiac Ablation System.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IOWA Approach Cardiac Ablation<br>Subjects who are treated with the IOWA Approach Cardiac Ablation System for paroxysmal atrial fibrillation. | Device: IOWA Approach Cardiac Ablation System<br>* Epicardial ablation using the IOWA Approach Cardiac Ablation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety: A Composite Safety Endpoint Consisting of the Subjects That Experience One or More Serious Adverse Events (SAEs) Related to the Investigational Procedure and/or Device Within 30 Days of the Ablation Procedure or Hospital Discharge. | A composite safety endpoint consisting of the proportion of subjects that experience one or more of the following serious adverse events (SAEs) related to the investigational procedure and/or device within 30 days of the PEF (pulsed electric field) ablation procedure or hospital discharge, whichever is later, except as noted below: Cardiac death Stroke and/or transient ischemic attack (TIA) Myocardial infarction (MI) Excessive bleeding Atrio-esophageal fistula Persistent post-surgical phrenic nerve paralysis at 12 months Severe pulmonary vein stenosis (>70%) | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasbility: Electrical Isolation of Posterior Left Atrium and Pulmonary Veins. | Proportion of subjects that achieve procedural success. Procedural success is defined as the creation of an electrically isolating box lesion encompassing the pulmonary veins and posterior left atrium using the study device. | 1 Day (Acute) |