ADVENT trial and AA burden sub-analysis

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About the study

ADVENT trial

The ADVENT trial¹ is the first randomized clinical trial that directly compared the FARAWAVE™ Pulsed Field Ablation (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

ADVENT trial: atrial arrhythmia (AA) burden sub-analysis

The ADVENT trial: atrial arrhythmia (AA) burden sub-analysis² compared the FARAWAVE™ 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: ADVENT trial

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

FARAPULSE 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 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 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 PFA vs 71.3% for thermal ablation

*Posterior probability >0.999

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 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 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

2. 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

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