Key takeaways:
- AF ablation with a novel contact force-sensing pulsed subject catheter was secure and acutely efficient.
- Three-month knowledge present promising sturdiness of pulmonary vein isolation.
First-in-human pulmonary vein isolation with a novel contact force-sensing pulsed subject ablation catheter was secure and demonstrated promising 3-month sturdiness for sufferers with paroxysmal atrial fibrillation, a speaker reported.
The outcomes of the Omny-IRE research of a novel contact force-sensing, large-tip focal pulsed subject ablation catheter (Omnypulse, Biosense Webster) for paroxysmal AF have been offered at Coronary heart Rhythm 2025.
AF ablation with a novel contact force-sensing pulsed subject catheter was secure and acutely efficient. Picture: Adobe Inventory
“The Omnypulse platform is an investigational system that mixes pulsed subject ablation remedy and mapping by way of the CARTO 3 system to deal with symptomatic paroxysmal atrial fibrillation,” Mattias Duytschaever, MD, electrophysiologist at AZ Sint-Jan Brugge Hospital in Bruges, Belgium, informed Healio. “The Omnypulse catheter is the primary large-tip, 12 mm large-focal catheter with contact force-sensing and a Trueref reference electrode to cut back the impression of far-field unipolar indicators. The Trupulse generator offers a bipolar, biphasic pulse utility to the catheter’s 12 electrodes. With the Carto 3 system software program used within the research, clinicians have been capable of get hold of a pulsed subject index worth for every ablation, which is calculated utilizing real-time contact pressure suggestions mixed with the variety of pulsed subject functions.”
For the current potential, single-arm, multicenter trial, the contact force-sensing pulsed subject catheter, which additionally options 3D mapping, was examined for the primary time in a cohort of 136 sufferers with paroxysmal AF at 13 facilities in Europe and Canada (imply age, 60 years; 69% males).
The first effectiveness endpoint was outlined as adenosine/isoproterenol-confirmed pulmonary vein isolation (PVI), with a efficiency objective of 90%. The first opposed occasions endpoint was outlined as all procedure-related opposed occasions inside 7 days of the process; cardiac tamponade/perforation inside 30 days; and dying, atrioesophageal fistula and pulmonary vein stenosis inside 90 days, all with a efficiency objective of 12%.
Within the current cohort, the common CHA2DS2-VASc rating was 1.6, imply left ventricular ejection fraction was 59% and imply left atrium diameter was 39.6 mm.
Acute procedural success was achieved in 100% of sufferers.
General, 108 sufferers underwent PVI with a later optimized workflow with a beneficial goal pulsed subject index of 550 on the anterior wall and 400 to 450 on the posterior wall.
“Following pulsed subject index steerage performs a key position in selling procedural consistency by quantifying power supply, contact pressure and lesion parameters,” Duytschaever informed Healio. “This allows constant dosing, and helps predict lesion depth based mostly on validated preclinical fashions to drive lesion sturdiness. In consequence, the pulsed subject index serves as a real-time procedural information for physicians, serving to them ship improved affected person outcomes.”
PVI with the contact force-sensing pulsed subject ablation catheter was sturdy, with 84.5% of veins remaining remoted at a imply follow-up of 82 days, in a subgroup of 29 contributors who underwent invasive remapping.
The typical process time was 106 minutes, with a imply of 61 pulsed subject ablations per process.
4 sufferers skilled opposed occasions. There have been three circumstances of procedure-related vascular access-site issues and/or bleeding, however they have been adjudicated as unrelated to the ablation catheter. There was one prevalence of pericarditis, which was adjudicated as probably procedure-related, however unrelated to the ablation catheter. No different opposed occasions have been reported.
“Whereas direct head-to-head comparisons usually are not but accessible, Omnypulse demonstrates comparable or superior acute success with excessive pulmonary vein sturdiness paired with promising early security,” Duytschaever mentioned. “The following steps embrace ongoing affected person follow-up, 12-month knowledge evaluation and advancing regulatory approvals based mostly on security and efficacy.”
Duytschaever mentioned through the presentation that 12-month knowledge from this European and Canadian cohort will likely be offered sooner or later, and a U.S. research is at the moment ongoing.
For extra info:
Mattias Duytschaever, MD, could be reached at AZ Sint-Jan Hospital, Ruddershove 10, 8000 Brugge, Belgium, and at mattias.duytschaever@azsintjan.be.
Sources/Disclosures
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Duytschaever M, et al. Late-breaking medical trials and science: Medical trials updates and registries (non-ACE). Introduced at: Coronary heart Rhythm 2025; April 24-27, 2025; San Diego.
Disclosures:
The Omny-IRE trial was funded by Biosense Webster. Duytschaever stories no related monetary disclosures.
