ADVENT trial and AA burden sub-analysis data summaries.

ADVENT trial, AA burden sub-analysis, long-term outcomes study

Overview

The ADVENT trial is the first randomised clinical trial that directly compared FARAPULSE™ PFA (with the FARAWAVE™ Pulsed Field Ablation (PFA) catheter) to standard-of-care thermal ablation—radiofrequency ablation (RFA) and cryoballoon ablation (CBA)—for the treatment of paroxysmal atrial fibrillation (PAF).

The ADVENT trial: AA burden sub-analysis compared FARAPULSE PFA (with the FARAWAVE PFA Catheter) to standard-of-care thermal for recurrent atrial arrythmia (AA).

The ADVENT long-term outcomes (LTO) study—an observational extension of the pivotal ADVENT trial—assessed effectiveness of FARAPULSE PFA (with the FARAWAVE PFA Catheter) vs thermal (RF or cryo) ablation out to 4 years.

About the study: ADVENT LTO

The ADVENT long-term outcomes (LTO) study1—an observational extension of the pivotal ADVENT trial—assessed AFib progression in patients out to 4 years (N=364, n=183 PFA, n=181 thermal ablation) who received ablation treatment with either FARAPULSE PFA (using the FARAWAVE PFA Catheter) or thermal (RF or cryo) ablation. This is the first long-term comparison of PFA vs thermal ablation from a randomised trial cohort following patients out to 4 years.

Download the ADVENT LTO study data summary

Key findings: ADVENT LTO

FARAPULSE PFA delivered greater effectiveness versus thermal ablation out to 4 years and comparable safety, with no long-term safety concerns observed.

FARAPULSE PFA outperformed thermal ablation

Icon of two open hands holding a heart, representing significantly improved quality of life in patients with low atrial arrhythmia burden.
Greater long-term effectiveness

73.8% (n=134/183) effectiveness at 4 years vs 64.3%(n=119/181)) for thermal ablation (P=0.12)

Hospital icon in a circle representing cardiology care and heart health
Fewer hospital-based interventions 

85.6%(n=158/183) freedom from hospital-based interventions at 4 years vs 78.6%(n=144/181) for thermal ablation (P=0.08)

Heart icon in a colorful circle on a white background.
Patients more likely to stay off anti-arrhythmic drugs (AADs)

11.5%(n=21/183) were prescribed AADs out to 4 years vs 20.4%(n=37/181) for thermal ablation (P=0.02)

Study design: ADVENT LTO

  • Observational extension of the ADVENT trial. Assessed effectiveness of FARAPULSE PFA (with the FARAWAVE PFA Catheter) vs thermal (RF or cryo) ablation out to 4 years.
  • N=364 paroxysmal AFib patients (PFA n=183, thermal n=181). Average follow-up was 3.6 years.
  • ADVENT LTO effectiveness endpoint defined as freedom from recurrence, cardioversion, or repeat ablation after the 3-month blanking period.

Effectiveness endpoint: ADVENT LTO

Greater long-term effectiveness vs thermal

About the study: ADVENT

The ADVENT trial2 was the first randomised clinical trial that directly compared the FARAWAVE PFA Catheter to standard-of-care thermal ablation devices—force-sensing radiofrequency ablation (RFA) or cryoballoon ablation (CBA)—for the treatment of paroxysmal atrial fibrillation (PAF).

Download the ADVENT trial data summary

Key findings: ADVENT trial

The ADVENT randomised controlled trial (RCT) included an experienced group of thermal ablators with limited clinical experience with the novel FARAPULSE PFA technology.  

FARAPULSE PFA demonstrated:

Stopwatch icon showing FARAPULSE shorter ablation procedure and reduced LA catheter dwell time compared to thermal ablation.

Significantly shorter ablation procedure time and catheter left atrium (LA) dwell time than thermal ablation 

Icon of a circle with an X, representing no serious thermal complications in PFA procedures, symbolizing safety.

PFA showed no instances of serious thermal complications 

Icon with a colored tick representing achievement of primary safety and efficacy endpoints, symbolizing non-inferiority in clinical results.

Met the primary safety and efficacy non-inferiority endpoints 

Study design: ADVENT trial

  • Multicentre, prospective, non-inferiority randomised controlled trial
  • Study sample size: 706 (80 roll-ins, 626 randomised)
  • Primary results included the 607-patient modified Intent-to-Treat (mITT)* cohort across 30 centres and 65 operators

Primary safety endpoint
A composite endpoint defined as serious adverse events related to either the use of an ablation catheter or the ablation procedure with onset within 7 days of the primary procedure and pulmonary vein stenosis or atrioesophageal fistula out to 12 months. 

Primary effectiveness endpoint
Both acute and chronic procedural success through 12 months which included freedom from re-abalation or use of amiodarone. After the 90-day blanking period, chronic success required freedom from AF, AFL, AT, cardioversion and no Class I/III AAD use. 

*mITT patients: ITT patients who received any energy delivery for pulmonary vein isolation (PVI) with the randomised endocardial ablation catheter at an Index/Rescheduled Index Procedure 

Primary endpoints met: ADVENT trial

The ADVENT study met the criterion for non-inferiority of FARAPULSE PFA to thermal ablation (posterior probability >0.999).  

Icon with a colored tick representing achievement of primary safety and efficacy endpoints, symbolizing non-inferiority in clinical results.

ADVENT met the primary safety endpoint for non-inferiority* vs thermal ablation at 12 months

2.1% for FARAPULSE PFA vs 1.5% for thermal ablation

Icon with a colored tick representing achievement of primary safety and efficacy endpoints, symbolizing non-inferiority in clinical results.

ADVENT met the primary efficacy endpoint for non-inferiority* vs thermal ablation at 12 months

73.3% for FARAPULSE PFA vs 71.3% for thermal ablation

*Posterior probability >0.999

About the study: ADVENT AA burden sub-analysis

The ADVENT trial: atrial arrhythmia (AA) burden sub-analysis3 compared the FARAWAVE PFA Catheter to standard-of-care thermal ablation (RFA and CBA) for recurrent atrial arrhythmia (AA). Patients treated with FARAPULSE showed a significantly greater reduction in AA burden than thermal ablation. 

Download the ADVENT trial: AA burden sub-analysis data summary

Key findings: AA burden sub-analysis

Icon of two open hands holding a heart, representing significantly improved quality of life in patients with low atrial arrhythmia burden.

Significantly greater quality of life (QoL) improvement in patients with AA burden <0.1% 

Hospital icon in a circle representing cardiology care and heart health

Significantly lower risk for redo ablation, cardioversion, and hospitalisation with AA Burden <0.1% vs. ≥0.1% 

Heart icon in a colorful circle on a white background.

FARAPULSE PFA patients were significantly more likely to have AA Burden <0.1% than RFA and CBA 

Study design and methods: AA burden sub-analysis

  • During ADVENT, post-ablation transtelephonic ECG monitoring (TTM) was collected weekly and for symptomatic episodes and 72-hour Holters were collected at 6 and 12 months  
  • The TTM and Holter data was used to calculate the AA burden. Total AA burden was estimated by the greater of 2 values:  
    • % AA over total duration of Holter data or  
    • % of weeks of TTM with AA over total # of weeks with TTMs recorded 
  • Quality of life was assessed at baseline and 12 months. This sub-analysis included 593 (97.7%) patients. 

AA burden sub-analysis by ablation modality

Bar graph showing that FARAPULSE patients were significantly more likely than RFA or CBA patients to have AA burden less than 0.1%.

References

1. Reddy, V. Y. (2026). Pulsed field versus conventional thermal ablation for paroxysmal atrial fibrillation: 4-year outcomes in the ADVENT-LTO study. Nature Medicine. https://doi.org/10.1038/s41591-026-04246-4

2. Reddy VY, Gerstenfeld EP, Natale A, et al., Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. New England Journal of Medicine.2023;Nov2;389(18):1660-1671. doi:10.1056/NEJMoa2307291  

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. 2024. 84(1): 61.74. https://doi.org/10.1016/j.jacc.2024.05.001

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