ADVENT Post-Approval Study

Purpose

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

Condition

  • Paroxysmal Atrial Fibrillation

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555-0737
Contact:
Elizabeth Hennessy
eahennes@utmb.edu

More Details

Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Sharon Mensah
1-612-403-7653
sharon.mensah@bsci.com

Detailed 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).