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Pulsed Field Ablation (PFA) for Atrial Fibrillation (AVANT GUARD Trial)

N/A
Recruiting
Led By Oussama Wazni, M.D.
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, and 36 months
Awards & highlights

AVANT GUARD Trial Summary

The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs.

Eligible Conditions
  • Atrial Fibrillation

AVANT GUARD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12, 24, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment.
Rate of intent to treat subjects, randomized to PFA with PFA System inserted into body, during index procedure or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious.
Secondary outcome measures
Atrial fibrillation burden between the pulsed field ablation and anti-arrhythmic drug arm, as measured by the LUX-Dx Insertable Cardiac Monitor and defined as the proportion of time an individual spends in AF during a period (expressed as a percentage).

AVANT GUARD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pulsed Field Ablation (PFA)Experimental Treatment1 Intervention
Pulsed Field Ablation (PFA) is used as the initial treatment for subjects with persistent atrial fibrillation (AF)
Group II: Anti-Arrhythmic Drug (AAD)Active Control1 Intervention
Anti-Arrhythmic Drug (AAD) is used as the initial treatment for subjects with persistent atrial fibrillation (AF)

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
719 Previous Clinical Trials
932,683 Total Patients Enrolled
69 Trials studying Atrial Fibrillation
28,023 Patients Enrolled for Atrial Fibrillation
Oussama Wazni, M.D.Principal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
2023. "Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06096337.
All > Paid Studies Pittsburgh > Knoxville
~258 spots leftby Dec 2025
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