ADVENT Post-Approval Study
Paroxysmal Atrial FibrillationThe ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation 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.
Study Location
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Institut universitaire de Cardiologie et de Pneumologie de QuebecQuébec, Quebec
Canada
Contact Study Team
Jean Champagne
Southlake Regional General Hospital
Southlake Regional General HospitalNewmarket, Ontario
Canada
Contact Study Team
Yaariv Khaykin
Institut de Cardiologie de Montreal-Hospital
Institut de Cardiologie de Montreal-HospitalMontréal, Quebec
Canada
Contact Study Team
Laurent Macle
- Study Sponsored By
- Boston Scientific Corporation
- Participants Required
- More Information
- Study ID:
NCT06431815