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Active Not Recruiting NCT06431815

ADVENT Post Approval Study

Conditions: Paroxysmal Atrial Fibrillation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 228
Sponsor: Boston Scientific Corporation

Location: Mobile Infirmary Medical Center Mobile Alabama

Summary

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06431815). StuddyBuddy aggregates publicly available trial information.