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ADVENT Post Approval Study
ADVENT Post Approval Study
Active Not RecruitingN/A
Sponsor: Boston Scientific Corporation
Conditions: Paroxysmal Atrial Fibrillation
Interventions: FARAPULSE™ Pulsed Field Ablation System
Countries: United States, Brazil, Canada, Chile
The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Eligibility criteria
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 least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.) * 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 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 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.
Locations (30)
- Mobile, Alabama, United States
- Scottsdale, Arizona, United States
- Oakland, California, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- Miami Beach, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Savannah, Georgia, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Jackson, Mississippi, United States
- Flushing, New York, United States
- New York, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Greenville, North Carolina, United States
- Harrisburg, Pennsylvania, United States
- Charleston, South Carolina, United States
- Columbia, South Carolina, United States
- Galveston, Texas, United States
- Houston, Texas, United States
- Houston, Texas, United States
- Norfolk, Virginia, United States
- Florianópolis, Santa Catarina, Brazil
- São Paulo, São Paulo, Brazil
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Concepción, Biobio, Chile