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Pulsed Field Ablation (PFA) Vs Anti-Arrhythmic Drug (AAD) Therapy As a First Line Treatment for Persistent 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

No Placebo-Only Group

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12, 24, and 36 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of intent to treat subjects with treatment success from the pulse field ablation treatment and Anti-Arrhythmic Drug treatment.

Rate of randomized PFA or PFA Assigned subjects with PFA System inserted into the body, during the index or repeat PFA procedure during blanking period, with device or procedure-related Composite Adverse Events that is serious.

Secondary study objectives

Atrial fibrillation burden between the pulsed field ablation and anti-arrhythmic drug arm, as the LUX-Dx Insertable Cardiac Monitor measures and defined as proportion of time individual spends in AF during a period (expressed as a percentage).