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FARAPULSE device image over blue pulse indication background.

   

ADVANTAGE AF US IDE Trial (Phase II)

First PFA Study in Persistent AFib Patients (N=255)1

At 29 US sites, 49 operators conducted 1-year continuous ECG monitoring with insertable cardiac monitors (ICMs) to provide detailed analysis of atrial arrhythmia burden reduction.

STUDY DESIGN
Multicenter, prospective, single-arm, IDE study

PATIENT POPULATION
Drug–refractory persistent AFib

REPORTED OUTCOMES
Safety, efficacy, atrial arrhythmia (AA) burden

FARAPULSE PFA proved to be effective in a hard-to-treat population.

Outcomes at 3 Months and 1 Year Post-Ablation

SAFETY


2.4%

safety event rate
at 3 months*


0

reported cases of pulmonary vein stenosis, atrioesophageal fistula, or phrenic nerve palsy

PRIMARY EFFICACY


73.4%

event-free rate at 12 months†


81%

remained free from symptomatic recurrence
at 12 months

RECURRENCE


52%

had no recurrence over 12 months

Of those who had recurrence:

70%

had no episodes >1 hour

94%

had no episodes
>24 hours

Low atrial arrhythmia (AA) burden resulted in low healthcare utilization (HCU) in advanced AFib patients.

The impact of AA burden: a clinically meaningful endpoint.
The traditional definition for recurrence in trials—episodes ≥30 seconds—may not reflect clinically meaningful AFib.2 AA burden, by contrast, is a sensitive, patient-centric measure of AFib control and treatment success across healthcare utilization (HCU) and quality of life.1

AA Burden and Healthcare Utilization (HCU) at 1 Year

AA BURDEN

Bar chart showing percentage of patients by total atrial arrhythmia (AA) burden from day 91–360. 71.6% of patients had AA burden ≤0.1%, 14% had 0.1%–1%, 7.2% had 1%–3%, and small percentages (≤1.6%) were distributed across higher burden categories up to 80%–90%.

71.6% of patients had ≤0.1% AA burden

HCU by AA BURDEN

Bar chart showing healthcare utilization by AA burden level. Patients with no AA burden had the lowest hospitalization, re-ablation, and drug escalation rates. HCU increased with higher AA burden, with the steepest rise in patients with burden above 1%.

*p<0.0125 compared to 0% burden group

AA burden <0.1% linked to lower HCU vs. AA burden >0.1% (p<0.0125)

LONGEST AA EPISODE

Bar chart showing the percentage of patients by their longest atrial arrhythmia (AA) episode between day 91 and 360. 52% of patients had no recurrence. Among those with recurrence: 7.6% had episodes under 10 minutes, 10.4% lasted 10–60 minutes, 10.0% lasted 1–6 hours, 14.0% lasted 6–24 hours, and 6.0% lasted more than 24 hours.

52% of patients had no AA recurrence 70% experienced AA episodes <1 hour

HCU by LONGEST AA EPISODE

Bar chart comparing healthcare utilization by longest AA episode duration. Patients with no recurrence had the lowest rates of hospitalization, re-ablation, or new/escalated antiarrhythmic drug use. HCU increased progressively with longer AA episodes, with the highest rates observed in patients whose episodes lasted more than 24 hours.

*p<0.01 compared to no recurrence group

No AA recurrence linked to lower HCU vs. episodes >1 hour (p<0.01)

10x

HCU was over tenfold higher in patients with 
AA burden >0.1% or episodes lasting >1 hour

Key Takeaways

  • FARAPULSE PFA met primary safety and efficacy endpoints with a low rate of major events
  • The majority of patients had virtually no AA burden at 12 months, associated with lower HCU
  • The majority of patients had no AA recurrence; of those that did, 70% had episodes <1 hour
View full publication


 

Next: See how FARAPULSE compares with cryoablation.

SINGLE SHOT CHAMPION Trial
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References:
1. Reddy VY, Gerstenfeld EP, Schmidt B, et al. Pulsed field ablation of persistent atrial fibrillation with continuous ECG monitoring follow-Up: ADVANTAGE AF-Phase 2. Circulation. Published online April 24, 2025. doi:10.1161/CIRCULATIONAHA.125.074485
2. Steinberg JS, O’Connell H, Li S, Ziegler PD. Thirty-second gold standard definition of atrial fibrillation and its relationship with subsequent arrhythmia patterns: analysis of a large prospective device database. Circ Arrhythm Electrophysiol. 2018;11(7):e006276. doi:10.1161/CIRCEP.118.006276

*Adverse events included cardiac tamponade or perforation (n=1), pulmonary edema (n=1), death (n=1), PFA system- or procedure-related cardiovascular or pulmonary event (n=2), stroke (n=3), and vascular access complication (n=1).
†Most common chronic treatment failure event was documented recurrence of a sustained atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia).