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FARAPULSE device image over blue pulse indication background.

   

ADVENT US IDE Trial

 

 

FARAPULSE PFA vs. Standard Thermal Ablation in Paroxysmal AFib Patients (N=607)1

At 30 US centers, 65 operators conducted 1:1 randomization to FARAPULSE PFA or thermal ablation, using either radiofrequency ablation (RFA) or cryoballoon ablation (CBA) at each site.

STUDY DESIGN
Multicenter, prospective, single-blind, randomized controlled study 

PATIENT POPULATION
Drug–refractory paroxysmal AFib

REPORTED OUTCOMES
Safety, efficacy, non-inferiority to thermal ablation 

FARAPULSE PFA delivered excellent outcomes comparable to thermal ablation.

Outcomes at 1 Year Post-Ablation

Comparison chart showing safety outcomes between FARAPULSE and thermal ablation at 12 months. FARAPULSE: 2.1% major adverse event rate. Thermal ablation: 1.5% major adverse event rate. The ADVENT trial met the primary safety endpoint for non-inferiority versus thermal ablation.
Comparison chart showing efficacy outcomes between FARAPULSE and thermal ablation at 12 months. FARAPULSE: 73.3% recurrence-free at one year. Thermal ablation: 71.3% recurrence-free at one year. The ADVENT trial met the primary efficacy endpoint for non-inferiority versus thermal ablation.

Significantly more patients achieved minimal atrial arrhythmia (AA) burden with FARAPULSE PFA.

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 at 1 Year3

Post-Ablation AA Burden Threshold of 0.1% by Modality 

Bar chart comparing the percentage of patients with different levels of atrial arrhythmia (AA) burden after ablation using FARAPULSE versus thermal ablation. Over 80% of FARAPULSE-treated patients had AA burden less than 0.1%, compared with over 70% in the thermal ablation group. Fewer FARAPULSE patients fell into higher AA burden categories (0.1%–9.9% and ≥10%) compared with thermal ablation patients.

FARAPULSE PFA-treated patients were significantly more likely
to have AA burden <0.1%

HCU is significantly lower with AA burden <0.1% vs. ≥10%3

Rate of Healthcare Utilization

AA Burden<0.1%0.1%–9.9%≥10%
Redo Ablations0.86%11.1%38.3%
Cardioversions0.65%9.9%17%
Hospitalizations1.72%14.8%42.6%

 

Quality of life is significantly higher with AA burden <0.1% vs. ≥10%3

Icon showing heart inside hands.

Fewer symptoms
More participation in activities
Fewer treatment concerns
Greater treatment satisfaction

Key Takeaways

  • FARAPULSE PFA met all primary and secondary endpoints for safety and efficacy
  • FARAPULSE PFA patients were significantly more likely to have AA burden <0.1% vs. those treated with thermal ablation
  • AA burden <0.1% translated to signifcantly greater quality of life and lower risk for redo ablation, cardioversion, and hospitalization
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FARAPULSE™ Pulsed Field Ablation System indications, safety, and warnings

References:
1. Reddy VY, Gerstenfeld EP, Natale A, et al. Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. N Engl J Med. 2023;389(18):1660–1671. doi:10.1056/NEJMoa2307291
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
3. Reddy V, Mansour M, Calkins H. et al., Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden. J Am Coll Cardiol. null2024, 0 (0).   https://doi.org/10.1016/j.jacc.2024.05.001