Phase
Condition
Atrial Fibrillation
Chest Pain
Cardiac Disease
Treatment
Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria::
Diagnosed with Symptomatic PAF (Physician's note indicating recurrentself-terminating AF). At least one (1) electrocardiographically documented AFepisode within twelve (12) months prior to enrollment. Electrocardiographicdocumentation may include, but is not limited to, electrocardiogram (ECG), Holtermonitor, or other electrocardiographical devices accepted by investigators
Failed at least one (1) Class I or Class III Antiarrhythmic Drug (AAD) as evidencedby recurrent symptomatic AF or has intolerable side effects or is contraindicated tothe Class I or Class III AAD
Able and willing to comply with all pre-procedure, post-procedure, and follow-uptesting and visit requirements
Willing and capable of providing consent
Exclusion
Exclusion Criteria:
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiaccause (e.g., untreated documented obstructive sleep apnea and acute alcoholtoxicity)
Previous LA ablation or surgery
Patients known to require ablation outside the PV region (atrioventricular reentranttachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrialflutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White)
Previously diagnosed with persistent AF (> 7 days in duration)
Severe dilatation of the LA (documented LAD >50mm antero-posterior diameter onimaging within 6 months prior to enrollment
Documented left atrium (LA) thrombus within 48 hours prior to the index procedure byTransesophageal Echocardiography (TEE), or by Intracardiac Echocardiography (ICE)prior to transeptal puncture during procedure
Documented severely compromised LVEF (LVEF <40%) by imaging within 6 months prior toenrollment
Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
History of blood clotting, bleeding abnormalities or contraindication toanticoagulation (heparin, warfarin, or dabigatran)
History of a documented thromboembolic event (including TIA) within the past 12months, or history of a documented left atrial appendage (LAA) thrombus
History of a documented symptomatic lacunar infarction within the past 12 months
Previous PCI/MI within the past 2 months
Coronary Artery Bypass Grafting (CABG) surgery within past 6 months
Valvular surgery, cardiac surgery (e.g., ventriculotomy, atriotomy) or valvularcardiac (surgical or percutaneous) procedure
Unstable angina pectoris within the past 6 months
Anticipated cardiac transplantation, cardiac surgery or other major surgery withinthe next 12 months
Significant pulmonary disease (e.g., restrictive pulmonary disease, constrictive orchronic obstructive pulmonary disease) or any other disease or malfunction of thelungs or respiratory system that produces severe chronic symptoms
Known significant PV anomaly that in the opinion of the investigator would precludeenrollment in this study
Has known pulmonary vein stenosis
Pre-existing hemi diaphragmatic paralysis
Acute illness, active systemic infection or sepsis
Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch orother abnormality that precludes catheter introduction or manipulation
Severe mitral regurgitation (Regurgitant volume 60 mL/beat, Regurgitant fraction 50%, and/or Effective regurgitant orifice area 0.40cm^2)
Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD),recently implanted (within 6 months) LAAO device or other implanted metal cardiacdevice within the cardiac space that may interfere with the energy field createdduring the ablation procedure.
Presence of a condition that precludes vascular access (such as IVC filter)
Significant congenital anomaly or a medical problem that in the opinion of theinvestigator would preclude enrollment in this study
Categorized as vulnerable population and requires special treatment with respect tosafeguards of well-being
Current enrollment in an investigational study evaluating another device or drug
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal),lactating, or who are of childbearing age and plan on becoming pregnant during thecourse of the clinical investigation
Life expectancy less than 12 months
History of massive hemorrhage within the past 6 months
Presenting contra-indications for the devices
Study Design
Connect with a study center
Royal Prince Alfred Hospital
Camperdown, 2050
AustraliaSite Not Available
Canberra Heart Rhythm
Garran, 2605
AustraliaSite Not Available
John Hunter Hospital
New Lambton Heights, 2305
AustraliaSite Not Available
Westmead Hospital
Westmead, 2145
AustraliaSite Not Available
Southlake Regional Health Centre
Newmarket, Ontario L3Y 2P9
CanadaSite Not Available
University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H3G 1A4
CanadaSite Not Available
Montreal Heart Institute
Montreal, Quebec H1T 1C8
CanadaSite Not Available
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