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ADVENT US IDE Trial

 

 

ADVENT trial overview

The ADVENT trial is the first randomized clinical trial that directly compared FARAPULSE™ PFA to standard-of-care thermal ablation—radiofrequency ablation (RFA) and cryoballoon ablation (CBA)—for the treatment of paroxysmal atrial fibrillation (PAF).1

The ADVENT trial: AA burden sub-analysis compared FARAPULSE PFA to standard-of-care thermal for recurrent atrial arrythmia (AA).2

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.3

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

Download the ADVENT trial data summary (PDF)

Key findings: ADVENT trial

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.

Key Takeaway

  • FARAPULSE PFA met all primary and secondary endpoints for safety and efficacy
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About the study: ADVENT AA burden sub-analysis2 

The ADVENT trial: AA burden sub-analysis2 compared the FARAWAVE™ PFA Catheter to standard-of-care thermal ablation (RFA and CBA) for recurrent AA. Patients treated with FARAPULSE™ PFA showed a significantly greater reduction in AA burden than thermal ablation. 

Study design: Post-ablation analysis using prospectively collected ADVENT IDE randomized controlled trial data. 72-hour Holter monitoring at 6 and 12 months.

Patient population: Drug-refractory paroxysmal AFib patients (N=593)

Reported outcomes: Atrial arrhythmia (AA) burden = proportion of time in atrial arrhythmia over a monitoring period; Quality of Life

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

Key findings: AA burden sub-analysis

Greater Reduction in AA Burden

Patients treated with FARAPULSE PFA were significantly more likely to experience AA burden <0.1% compared to thermal ablation. 

Lower Healthcare Utilization

AA burden <0.1% was associated with significantly lower rates of

  • Redo ablation
  • Cardioversion
  • Hospitalization

Improved Quality of Life

Patients with AA burden <0.1% experienced:

  • Greater symptom improvement

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, was measured through transtelephonic ECG monitoring (TTM) collected weekly or for symptomatic episodes and 72-hour Holters were collected at 6 and 12 months. The TTM and Holter data was used to calculate AA burden by percentage of time. Quality-of-life (QoL) assessments were collected from patients and there was a significantly greater QoL improvement in patients with AA burden <0.1% versus ≥10%.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%

First Long-Term Data from a Randomized PFA Cohort (N=364)3

This is the first long-term comparison of PFA vs thermal ablation from a randomized trial cohort following patients out to 4 years.

Study design: 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

Patient population: Paroxysmal AFib patients (N=364, n=183 PFA, n=181 thermal ablation)

Reported outcomes:  Safety, efficacy – freedom from recurrence, cardioversion, or repeat ablation after the 3-month blanking period

Download the ADVENT LTO study data summary (PDF)

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

Greater long-term effectiveness vs thermal

Fewer Hospital-Based Interventions
 

Greater freedom from hospital-based arrythmia intervention

Patients More Likely to Stay Off Anti-Arrhythmic Drugs (AADs)

FARAPULSE PFA patients more likely to stay off anti-arrythmia drugs
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. 2024. 84(1): 61.74. https://doi.org/10.1016/j.jacc.2024.05.001
3. 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