Clinical leadership in PFA
Extensively researched and used in over 200,000 patients globally, FARAPULSE Pulsed Field Ablation holds more published clinical evidence than any other Pulsed Field Ablation (PFA) system.
Transformative clinical leadership in PFA
ADVANTAGE AF (Phase I) key findings
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 atrial (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
ADVANTAGE AF US IDE (Phase I) clinical trial discussion
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 12 months, which met the 12.0% performance goal
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.
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.
Single Shot Champion Clinical Trial
The SINGLE SHOT CHAMPION trial, a rigorously conducted investigator-initiated study, has unveiled the superior effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) System in treating symptomatic paroxysmal atrial fibrillation (AF) compared to Arctic Front Advance™ Cryoballoon Ablation system. This randomised controlled trial compared the FARAPULSE PFA System with the Arctic Front Advance™ cardiac cryoablation catheter, demonstrating a remarkable 62.9% recurrence-free rate at 12 months for FARAPULSE, compared to 49.3% for Arctic Front Advance™. Conducted across two leading hospitals in Switzerland, the trial involved 210 patients and utilized continuous rhythm monitoring with the Reveal LINQ™ device to ensure comprehensive efficacy assessment. Below, you will find a testimonial from Prof. Reichlin and a detailed clinical data summary available for download.
ADVENT Pivotal Trial
Watch Dr Vivek Y. Reddy discuss the randomized ADVENT Pivotal Trial results showing shorter ablation procedure and catheter left atrium (LA) dwell times - PFA Vs Thermal Ablation
Discover more about the ADVENT Pivotal Trial. It is the first randomised clinical trial that directly compares FARAPULSE PFA to standard-of-care thermal ablation devices (force-sensing radiofrequency (RFA) or cryoballoon ablation (CBA)), for the treatment of paroxysmal atrial fibrillation (PAF).
MANIFEST-17K Multicentre Registry
Watch Dr Ante Anić discuss the MANIFEST-17K results - the largest real-world safety registry of any PFA system
MANIFEST-PF 1 year outcomes
Review the findings and the outcome results at 1 year from the multi-national study on the methods, efficacy and safety of Pulsed Field Ablation (PFA) in a real-world setting.
