Study for Atrial Fibrillation

(ADVENTPAS Trial)

Not currently recruiting at 37 trial locations
EL
SM
GR
Overseen ByGiovanni Raciti
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Scientific Corporation
Must be taking: Class I or III antiarrhythmics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the FARAPULSE Pulsed Field Ablation (PFA) System for individuals with paroxysmal atrial fibrillation, a type of irregular heartbeat that does not improve with standard medications. The study is observational, tracking outcomes after treatment to assess its effectiveness in real-world settings. It suits individuals who have tried at least one medication for their irregular heartbeat without success. Participants must attend regular follow-ups and testing at the study sites. As an unphased study, this trial provides a unique opportunity to contribute to understanding the real-world effectiveness of this treatment.

Why are researchers excited about this trial?

Without specific details about the treatment or condition that the ADVENT Post Approval Study is targeting, we can't dive into the specifics of what makes it unique. However, researchers are generally excited about new treatments in clinical trials because they often offer novel approaches or improvements over existing therapies. This could include a new mechanism of action that targets the condition more precisely, a new delivery method that improves how the drug is administered and absorbed, or a new active ingredient that could be more effective or have fewer side effects. These innovations have the potential to enhance patient outcomes and provide options where current treatments may fall short.

Who Is on the Research Team?

SE

Stavros E Mountantonakis, MD, MBA

Principal Investigator

Northwell Health, Lenox Hill Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I have atrial fibrillation that hasn't improved with medication and need a FARAPULSE treatment.
I am willing and able to give my consent for treatment.
I am willing and able to follow all study requirements at the approved site.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulmonary vein isolation using the FARAPULSE Pulsed Field Ablation System

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of serious adverse events and treatment success

12 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

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