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ADVENT Post Approval Study
ADVENT Post Approval Study

NCT06431815

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