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
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.
Key Findings:
- At 12 months, the primary safety event rate was 2.3% [5.1% UCL] which met the 12.0% performance goal.
- At 12 months, the primary effectiveness rate was 63.5% [57.3% LCL] which met the acceptance criteria of 40.0%.
- 4.6% LA re-ablation rate with 84.4% PV durability at redo and 68.8% PW durability at redo.
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: 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.
Watch Dr Vivek Y. Reddy and Brad Sutton, Global Chief Medical Offer review ADVANTAGE trial results
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.
