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
Galveston, Texas 77555-0737
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
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).