A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation (PFA) Versus Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation
Objective
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.
Study Arms
- Experimental: Pulsed Field Ablation (PFA)
- Active Comparator: Anti-Arrhythmic Drug (AAD)
Eligibility
- Age ≥ 18 years of age, or older if specified by local law
- Have symptomatic persistent AF, confirmed by both:
- Documentation, within 180 days of randomization, or treatment assignment for roll-in subjects, of either: i. A 24-hour continuous ECG recording (from any regulatory cleared rhythm monitoring device) confirming continuous AF, OR ii. Two ECGs (from any regulatory cleared rhythm monitoring device) showing continuous AF taken at least 7 days apart
- Documentation, such as physician note, of persistent continuous AF for > 7 days and ≤ 365 days
- Willing and capable of providing informed consent
- Willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center
- Willing to receive LUX-Dx™ insertable cardiac monitor (ICM) during the study or already has a LUX-Dx™ ICM that was inserted ≤ 6 months of consent
NCT ID
NCT06096337
