Phase
Condition
Chest Pain
Cardiac Disease
Arrhythmia
Treatment
FARAPULSE™ Pulsed Field Ablation System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System*; (Subjects refractory, or intolerant or contraindicated to at leastone class I or III antiarrhythmic medication or contraindicated to any class I orIII medications.)
Subjects who are willing and capable of providing informed consent;
Subjects who are willing and capable of participating in all testing and follow-upassociated with this clinical study at an approved clinical investigational site;
Subjects who are of legal age to give informed consent specific to the national law.
For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable CardiacMonitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICMinserted per the investigator's standard of care, up to 7 days after the ablationprocedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
Exclusion
Exclusion Criteria:
Subjects with any known contraindication to an AF ablation or anticoagulation,including those listed in the Instructions For Use (IFU);
Subjects with any prior left atrium (LA) ablation;
Subjects who may need an ablation in the left atrium besides PVI, such as forleft-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrialtachycardia (AT) or atypical left-sided atrial flutter (AFL);
Women of childbearing potential who are or plan to become pregnant during the timeof the study (assessment per investigator's discretion);
Life expectancy of < 1 year, per investigator's medical judgement.
Study Design
Study Description
Connect with a study center
Sos Cardio Servicoshospitalares Ltda
Florianópolis, Santa Catarina 88030-000
BrazilSite Not Available
Instituto do Coração do HCFMUSP
São Paulo, Sao Paulo 05403-900
BrazilSite Not Available
Southlake Regional General Hospital
Newmarket, Ontario L3Y8C3
CanadaSite Not Available
Institut de Cardiologie de Montreal-Hospital
Montréal, Quebec H1T 1C8
CanadaSite Not Available
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec G1V 4G5
CanadaActive - Recruiting
Hospital Regional de Concepcion
Concepción, Biobio 4070022
ChileSite Not Available
Mobile Infirmary Medical Center
Mobile, Alabama 36608
United StatesActive - Recruiting
Scottsdale Healthcare - Shea
Scottsdale, Arizona 85258
United StatesActive - Recruiting
Alta Bates Summit Medical Center
Oakland, California 94609
United StatesActive - Recruiting
Washington Hospital Center
Washington, District of Columbia 20010
United StatesActive - Recruiting
Florida Heart Rhythm Specialists, PLLC
Fort Lauderdale, Florida 33308
United StatesActive - Recruiting
Baptist Medical Center
Jacksonville, Florida 32207
United StatesActive - Recruiting
Mount Sinai Medical Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
Tallahassee Memorial Hospital
Tallahassee, Florida 32308
United StatesActive - Recruiting
AdventHealth Tampa
Tampa, Florida 33613
United StatesActive - Recruiting
Memorial Health University Medical Center
Savannah, Georgia 31404
United StatesActive - Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
University of Mississippi Medical Center
Jackson, Mississippi 39216-4504
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10461
United StatesSite Not Available
New York Hospital Queens
Flushing, New York 11355
United StatesSite Not Available
Columbia University Medical Center
New York, New York 10019
United StatesActive - Recruiting
Northwell Health
New York, New York 10075
United StatesActive - Recruiting
East Carolina University Medical Center
Greenville, North Carolina 27834
United StatesSite Not Available
Hillcrest Medical Center
Tulsa, Oklahoma 74104
United StatesSite Not Available
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania 17104
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Prisma Health Richland Hospital
Columbia, South Carolina 29203
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
University of Texas Medical Branch
Galveston, Texas 77555-0737
United StatesActive - Recruiting
Orion Medical
Houston, Texas 77034
United StatesActive - Recruiting
University of Texas Houston Health Science Center
Houston, Texas 77030
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesActive - Recruiting
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
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