RecruitingNot Applicable

A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation

United States699 participantsStarted 2025-11-07

Plain-language summary

The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).

Who can participate

Age range18 Years

SexALL

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

✓. ≥ 18 years of age, or older if required by local law
✓. Have symptomatic drug-refractory1, persistent AF2, confirmed by both:
✓. Willing and capable of providing informed consent
✓. Willing and capable of participating in all follow-up assessments and 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 (i.e., within 180 days) of consent, and willing to comply to the LUX-Dx Latitude Clarity transmission instructions

Exclusion criteria

✕. Any of the following atrial conditions:
✕. Left atrial anteroposterior diameter ≥ 5.5 cm, or if1 LA diameter not available, non-indexed volume \>100 ml (physician note or imaging)
✕. Any prior left atrial ablation
✕. Any prior atrial surgery
✕. Current atrial myxoma
✕. Current left atrial thrombus
✕. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
✕. Any of the following cardiovascular conditions:

What they're measuring

Primary Safety Endpoint

Timeframe: 60 Days

Primary Effectiveness Endpoint

Timeframe: 365 Days

Trial details

NCT IDNCT07187115

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07

Contact for this trial

Jackie Lin

+16123608544 jackie.lin@bsci.com

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials