Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
228 participants
OBSERVATIONAL
2024-09-25
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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FARAPULSE™ Pulsed Field Ablation System
De-novo pulmonary vein isolation (PVI) will be performed with the FARAPULSE Pulsed Field Ablation (PFA) System.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who are willing and capable of providing informed consent;
* Subjects who are willing and capable of participating in all testing and follow-up associated 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 Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure.
Exclusion Criteria
* Subjects with any prior left atrium (LA) ablation;
* Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL);
* Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion);
* Life expectancy of \< 1 year, per investigator's medical judgement.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Stavros E Mountantonakis, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Northwell Health, Lenox Hill Hospital
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
Alta Bates Summit Medical Center
Oakland, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Florida Heart Rhythm Specialists, PLLC
Fort Lauderdale, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
AdventHealth Tampa
Tampa, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
New York Hospital Queens
Flushing, New York, United States
Columbia University Medical Center
New York, New York, United States
Northwell Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
East Carolina University Medical Center
Greenville, North Carolina, United States
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas Houston Health Science Center
Houston, Texas, United States
Orion Medical
Houston, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Sos Cardio Servicoshospitalares Ltda
Florianópolis, Santa Catarina, Brazil
Instituto do Coração do HCFMUSP
São Paulo, São Paulo, Brazil
Institut de Cardiologie de Montreal-Hospital
Montreal, Quebec, Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
Hospital Regional de Concepcion
Concepción, Región del Biobío, Chile
Countries
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Other Identifiers
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PF304
Identifier Type: -
Identifier Source: org_study_id