ADVENT Post-Approval Study (ADVENT PAS)

Boston Scientific

Status: Enrolling

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: FARAPULSE™ Pulsed Field Ablation System

Study type: Observational

Funder types: Industry

Identifiers

NCT06431815

PF304

Details and patient eligibility

About

The ADVENT Post Approval Study (PAS) is a prospective, global, multicenter, observational study.

Full description

The objective of ADVENT PAS is to evaluate the long-term safety and effectiveness profile of the FARAPULSE Pulsed Field Ablation System when used to perform pulmonary vein isolation (PVI) in the de-novo ablation treatment of patients with paroxysmal atrial fibrillation (PAF).

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.