Phase
Condition
Arrhythmia
Chest Pain
Dysrhythmia
Treatment
PFA Ablation catheter
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentationrequirements are as follows:
Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes ofPAF within the 6 months prior to enrollment AND
One electrocardiographically documented PAF episode within 12 months prior toenrollment. NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.
Plans to undergo a catheter ablation procedure due to symptomatic PAF and isrefractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
At least 18 years of age
Able and willing to comply with all trial requirements including pre- procedure,post-procedure, and follow-up testing and requirements
Informed of the nature of the trial, agreed to its provisions, and has providedwritten informed consent as approved by the Institutional Review Board/EthicsCommittee (IRB/EC) of the respective clinical trial site.
Exclusion
Exclusion Criteria:
Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
Arrhythmia due to reversible causes including thyroid disorders, acute alcoholintoxication, electrolyte imbalance, severe untreated sleep apnea, and other majorsurgical procedures in the preceding 90 days
Known presence of cardiac thrombus
Left atrial diameter (LAD) > or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure
Left ventricular ejection fraction (LVEF) < or equal to 35% as assessed withechocardiography or computerized tomography (CT) within 180 days prior to the indexprocedure
New York Heart Association (NYHA) class III or IV heart failure
Body mass index > or equal to 40 kg/m2
Pregnant or nursing
Patients who have had a ventriculotomy or atriotomy within the preceding 28 days ofprocedure
Myocardial infarction (MI), acute coronary syndrome, percutaneous coronaryintervention (PCI), or valve or coronary bypass grafting surgery within preceding 90days
Stroke or TIA (transient ischemic attack) within the last 90 days
Heart disease in which corrective surgery is anticipated within 180 days afterprocedure
History of blood clotting or bleeding abnormalities including thrombocytosis,thrombocytopenia, bleeding diathesis, or suspected anti- coagulant state
Contraindication to long-term anti-thromboembolic therapy
Patient unable to receive heparin or an acceptable alternative to achieve adequateanticoagulation
Known sensitivity to contrast media (if needed during the procedure) that cannot becontrolled with pre-medication
Previous left atrial surgical or left atrial catheter ablation procedure (includingleft atrial appendage (LAA) closure device)
Plans to have an LAA closure device implanted during the follow-up period
Presence of any condition that precludes appropriate vascular access
Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
Previous tricuspid or mitral valve replacement or repair
Patients with prosthetic valves
Patients with a myxoma
Patients with an interatrial baffle or patch as the transseptal puncture couldpersist and produce an iatrogenic atrial shunt
Stent, constriction, or stenosis in a pulmonary vein
Rheumatic heart disease
Hypertrophic cardiomyopathy
Active systemic infection
Renal failure requiring dialysis
Severe 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
Presence of an implantable therapeutic cardiac device including permanent pacemaker,biventricular pacemaker, or any type of implantable cardiac defibrillator (with orwithout biventricular pacing function) or planned implant of such a device for anytime during the follow-up period. Presence of an implantable loop recorder isacceptable as long as it is removed prior to insertion of the investigationaldevice.
Patient is currently participating in another clinical trial or has participated ina clinical trial within 30 days prior to screening that may interfere with thisclinical trial without pre-approval from this study Sponsor
Unlikely to survive the protocol follow up period of 12 months
Presence of other medical, anatomic, comorbid, social, or psychological conditionsthat, in the investigator's opinion, could limit the subject's ability toparticipate in the clinical investigation or to comply with follow-up requirements,or impact the scientific soundness of the clinical investigation results.
Individuals without legal authority
Individuals unable to read or write
Study Design
Study Description
Connect with a study center
KH Wiener Neustadt
Wiener Neustadt, L Austr 2700
AustriaSite Not Available
KH Wiener Neustadt
Wiener Neustadt 2761353, L Austr 2700
AustriaSite Not Available
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Dzukija 08661
LithuaniaSite Not Available
Vilnius University Hospital Santariskiu Klinikos
Vilnius 593116, Dzukija 08661
LithuaniaSite Not Available
Erasmus Medical Center - Thoraxcenter
Rotterdam, S Holln 3015 CE
NetherlandsSite Not Available
Erasmus Medical Center - Thoraxcenter
Rotterdam 2747891, S Holln 3015 CE
NetherlandsSite Not Available
HonorHealth
Scottsdale, Arizona 85258
United StatesSite Not Available
HonorHealth
Scottsdale 5313457, Arizona 5551752 85258
United StatesSite Not Available
Arkansas Heart Hospital
Little Rock, Arkansas 72211
United StatesSite Not Available
Arkansas Heart Hospital
Little Rock 4119403, Arkansas 4099753 72211
United StatesSite Not Available
Stanford University Medical Center
Stanford, California 94305
United StatesSite Not Available
Stanford University Medical Center
Stanford 5398563, California 5332921 94305
United StatesSite Not Available
South Denver Cardiology Associates PC
Littleton, Colorado 80120
United StatesSite Not Available
South Denver Cardiology Associates PC
Littleton 5429032, Colorado 5417618 80120
United StatesSite Not Available
Mercy Hospital
Miami, Florida 33133
United StatesSite Not Available
AdventHealth Orlando
Orlando, Florida 32803
United StatesSite Not Available
Tallahassee Research Institute
Tallahassee, Florida 32308
United StatesSite Not Available
HCA Florida Mercy Hospital
Miami 4164138, Florida 4155751 33133
United StatesSite Not Available
AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803
United StatesSite Not Available
Tallahassee Research Institute
Tallahassee 4174715, Florida 4155751 32308
United StatesSite Not Available
Piedmont Athens Regional Medical Center
Athens, Georgia 30606
United StatesSite Not Available
Piedmont Athens Regional Medical Center
Athens 4180386, Georgia 4197000 30606
United StatesSite Not Available
Loyola University Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
Loyola University Medical Center
Maywood 4901514, Illinois 4896861 60153
United StatesSite Not Available
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas 66211
United StatesSite Not Available
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park 4276873, Kansas 4273857 66211
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48104
United StatesSite Not Available
Providence Hospital
Southfield, Michigan 48075
United StatesSite Not Available
University of Michigan Medical Center
Ann Arbor 4984247, Michigan 5001836 48104
United StatesSite Not Available
Henry Ford Providence Southfield Hospital
Southfield 5010636, Michigan 5001836 48075
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Heart Rhythm of Mississippi, Research Division
Flowood, Mississippi 39232
United StatesSite Not Available
The Heart Rhythm Center of MS
Gulfport 4428667, Mississippi 4436296 39501
United StatesSite Not Available
Bryan Heart Medical Center
Lincoln, Nebraska 68506
United StatesSite Not Available
Bryan Heart Medical Center
Lincoln 5072006, Nebraska 5073708 68506
United StatesSite Not Available
New York Presbyterian Hospital/Cornell University
New York, New York 10021
United StatesActive - Recruiting
New York University Hospital
New York, New York 10016
United StatesSite Not Available
NYU Langone Health
New York 5128581, New York 5128638 10016
United StatesSite Not Available
New York Presbyterian Hospital/Cornell University
New York 5128581, New York 5128638 10021
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
Duke University Medical Center
Durham 4464368, North Carolina 4482348 27705
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Centennial Medical Center
Nashville, Tennessee 37203
United StatesActive - Recruiting
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
United StatesSite Not Available
Tristar Centennial Medical Center
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Vanderbilt Heart & Vascular Institute
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
Texas Cardiac Arrhythmia
Austin, Texas 78705
United StatesSite Not Available
Ocelot Medical Research Group
Dallas, Texas 75230
United StatesSite Not Available
Medical City Fort Worth
Fort Worth, Texas 76104
United StatesSite Not Available
Houston Methodist The Woodlands Hospital
Shenandoah, Texas 77385
United StatesSite Not Available
Texas Cardiac Arrhythmia
Austin 4671654, Texas 4736286 78705
United StatesSite Not Available
Ocelot Medical Research Group
Dallas 4684888, Texas 4736286 75230
United StatesSite Not Available
Medical City Fort Worth
Fort Worth 4691930, Texas 4736286 76104
United StatesSite Not Available
Houston Methodist The Woodlands Hospital
Shenandoah 4728287, Texas 4736286 77385
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23219
United StatesSite Not Available
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23219
United StatesSite Not Available
The Heart Institute at Virginia Mason
Seattle, Washington 98111
United StatesSite Not Available
The Heart Institute at Virginia Mason
Seattle 5809844, Washington 5815135 98111
United StatesSite Not Available

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