ADVANTAGE AF US IDE clinical trial

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About the study

The ADVANTAGE AF US IDE Phase I clinical trial¹ studied the safety and effectiveness of the FARAWAVE™ Pulsed Field Ablation (PFA) Catheter in patients with persistent atrial fibrillation (PersAF), combining pulmonary vein isolation (PVI) and posterior wall ablation (PWA).

Download ADVANTAGE Phase I data summary

The ADVANTAGE AF US IDE Phase II clinical trial¹ included the addition of cavo-tricuspid isthmus (CTI) isolation with the FARAPOINT™ Pulsed Field Ablation (PFA) Catheter and continuous monitoring with the LUX-Dx™ Insertable Cardiac Monitor System (ICM) for continuous heart rhythm monitoring.

Download ADVANTAGE Phase II data summary

CAUTION: Investigational Device. Limited by Federal (or US) law to investigational use only. Ablation of patients with persistent atrial fibrillation or ablation beyond pulmonary vein isolation are outside the labeled indication(s) for use of the FARAWAVE™ PFA Catheter with the FARAPULSE PFA System. FARAWAVE™ NAV PFA Catheter was not used in this study. Phase II included the addition of studying the focal FARAPOINT™ Pulsed Field Ablation Catheter for cavotricuspid isthmus (CTI) ablation to treat typical atrial flutter which is not available for sale.

Primary endpoints met (Phase I)

ADVANTAGE AF US IDE (Phase I) clinical trial discussion

Hear Dr. Vivek Reddy (Principal Investigator) discuss ADVANTAGE AF Phase I results with Dr. Brad Sutton (Chief Medical Officer for AF Solutions at Boston Scientific).

Key findings (Phase I)

2.3%

[5.1% UCL] Primary safety event rate at 12 months, which met the 12.0% performance goal

63.5%

[57.3% LCL] Primary effectiveness rate at 12 months, which met 40.0% acceptance criteria

4.6%

Left artial (LA) re-ablation rate, with 84.4% pulmonary vein (PV) durability and 68.8% pulmonary wall (PW) durability

85.3%

Patients free from documented symptomatic AA recurrence at 12 months

Study design and methods (Phase I)

43 US/OUS sites
87 investigators (67% of the investigators had no prior FARAWAVE experience)
260 PersAF patients underwent PVI and PWA with post-blanking period monitoring of 2x monthly TTM, symptomatic and 24-hour Holter monitoring at 6 and 12 months, and 12-lead ECGs at 3 and 12 months

ADVANTAGE AF (Phase I) primary endpoints met

Graph showing FARAPULSE PFA System met primary safety endpoint in ADVANTAGE AF trial with low rate of adverse events.

Primary safety endpoint (Phase I)
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.

Chart showing 63.5% effectiveness at 12 months for FARAPULSE PFA in ADVANTAGE AF Phase I trial.

Primary effectiveness endpoint (Phase I)
A composite endpoint defined as acute and chronic ablation success through 12 months. After the 90-day blanking period, chronic success was defined as freedom from AF, AFL or AT, re-ablation, cardioversion and use of a new or escalated dose of Class I/III AADs or Amiodarone.

Get full results from the ADVANTAGE AF (Phase I) study

Download ADVANTAGE AF Phase I data summary

Download infographic

Primary endpoints met (Phase II)

ADVANTAGE AF IDE (Phase II) Clinical Trial is the first trial to assess PFA effectiveness using the focal FARAPOINT™ Pulsed Field Ablation Catheter and LUX-DX™ Insertable Cardiac Monitor (ICM) System.

ADVANTAGE AF key findings (Phase II)

2.4%

[97.5% UCL = 5.2%]
Primary safety event rate at 3 months

73.4%

[97.5% LCL = 67.5%]
Primary effectiveness event-free rate at 12 months

96.4%

[97.5% LCL = 91.7%]
CTI primary effectiveness event-free rate at 12 months

Patients were monitored with the LUX-Dx ICM which eliminated monitoring bias giving a more comprehensive assessment of ablation efficacy. At 12 months, over half of patients treated with FARAPULSE had zero episodes of AA recurrence, and 70% had less than 1 hour of AA burden.

52% had no AA recurrence, 70% had <1 hr AA duration at 12 months per LUX-Dx and BeatLogic AI analysis.

LUX-Dx detected atrial arrhythmia episodes were adjudicated by BeatLogic™. The BeatLogic algorithm is a cloud-based ECG analysis platform that leverages artificial intelligence (AI) algorithms and deep learning to automate ECG interpretation.

ADVANTAGE AF study design and methods (Phase II)

29 US sites
49 Investigators
255 PersAF patients

PVI and PWA with FARAWAVE, CTI with FARAPOINT (per protocol)

Continuous monitoring with LUX-Dx ICM and 12-lead ECG at 3 and 12 months

LUX-Dx was used to simulate traditional, symptomatic and Holter monitoring. LUX-Dx detected atrial arrhythmia episodes were adjudicated by BeatLogic to calculate AA burden.

Primary safety endpoint (Phase II)

A composite endpoint defined as: 1) serious adverse event related to either the use of an ablation catheter or the ablation procedure with onset within 7 days of the primary procedure, 2) death, cardiac tamponade/perforation, pericarditis, cardiovascular or pulmonary adverse event related to either the use of the ablation system or procedure out to 30 days and 3) pulmonary vein stenosis or atrio-esophageal fistula out to 3 months.

Primary effectiveness endpoint (Phase II)

A composite endpoint defined as acute procedural success (isolation of PV and LAPW) and chronic ablation success through 12 months. After the 90-day blanking period, chronic success was defined as freedom from AF/AFL/AT recorded on the LUX-Dx ICM (≥30 seconds on simulated bimonthly cardiac event monitor periods ≥30 second or 24-hour Holter monitor periods at Day 180 and 360, and ≥10 seconds on ECG), re-ablation, cardioversion and use of a new or escalated dose of Class I/III AADs or Amiodarone. 

Primary CTI effectiveness endpoint (Phase II)

Composite endpoint of CTI dependent AFL acute (bidirectional conduction block at index procedure) and chronic (freedom from documented CTI dependent AFL (≥ 10 sec on ECG) without a repeat CTI ablation) procedural success.

Get full results from the ADVANTAGE AF (Phase II) study

Download ADVANTAGE AF Phase II data summary

FARAPULSE™ Pulsed Field Ablation System indications, safety and warnings

LUX-Dx™ Insertable Cardiac Monitor System Indications, Safety and Warnings

References

1. Reddy, V., et al., "Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous ECG Monitoring Follow-Up: ADVANTAGE AF-Phase 2." Circulation 151.0 (2025).

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