Active — Not RecruitingNot Applicable

ADVENT Post Approval Study

United States, Brazil, Canada228 participantsStarted 2024-09-25

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.

Timeframe: 12 Months

Treatment success, defined as the incidence of subjects with successful isolation of clinically relevant pulmonary veins AND patients without recurrence or interventions for AF, AFL, AT after the blanking period through 12 months.

Timeframe: 12 Months

Trial details

NCT IDNCT06431815

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-10

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Composite incidence of patients with procedure-related and device-related serious adverse events at 7-Days and 12-months post-Index Procedure.

Timeframe: 12 Months