FARAPOINT™ Pulsed Field Ablation Catheter FDA APPROVED: See how it works

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

Overview

The ADVENT trial is the first randomized 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.

ADVENT LTO
ADVENT
ADVENT sub-analysis

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 randomized 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.

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)

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)

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 trial

The ADVENT trial² was the first randomized 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 randomized controlled trial (RCT) included an experienced group of thermal ablators with limited clinical experience with the novel FARAPULSE PFA technology.

FARAPULSE PFA demonstrated:

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

PFA showed no instances of serious thermal complications

Met the primary safety and efficacy non-inferiority endpoints

Study design: ADVENT trial

Multicenter, prospective, non-inferiority randomized controlled trial
Study sample size: 706 (80 roll-ins, 626 randomized)
Primary results included the 607-patient modified Intent-to-Treat (mITT)* cohort across 30 centers 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 atrio-esophageal 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 randomized 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).

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

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 PFA 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

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

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

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%.

FARAPULSE™ Pulsed Field Ablation System indications, safety and warnings

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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