Clinical data


DISRUPT-AF real-world registry1

Safe, efficient single-catheter map and ablate workflow with the FARAWAVE™ NAV Pulsed Field Ablation (PFA) Catheter, visualized with FARAVIEW™ Software Module on the OPAL HDx™ Mapping System. The DISRUPT-AF real-world registry (n=477) showed a 0.2% catheter-related complication event rate, predictable procedures and an average fluoroscopy time of 3.8 minutes.

NAVIGATE-PF trial2

The NAVIGATE-PF clinical trial was a multi-center, first-in-human feasibility study that assessed the acute and chronic accuracy of FIELDTAG™ Technology on the FARAVIEW™ Software Module in visualizing pulsed field energy delivery by the FARAWAVE™ NAV catheter. The study included two phases:
Phase I (acute assessment):

  • Phase 1 included 30 patients that underwent PV isolation, with 30% also receiving posterior wall ablation.
  • PFA markers were placed during PFA application and high-quality, post-ablation HD maps with INTELLAMAP ORION™ Mapping Catheter were completed in 15 pts. PFA markers were overlaid on the HD map and contours were drawn at the outer border of the low voltage areas (defined as ≤0.5mV) where at least 2 overlapping PFA markers were dropped.

Phase II (chronic assessment):

  • Included 20 patients at 1 center to evaluate chronic lesion durability and alignment between acute PFA tag locations and chronic low voltage borders.

NAVIGATE-PF clinical data summary (PDF)

NAVIGATE-PF3: 60 day remap

60-day remapping after FARAWAVE NAV PFA Catheter ablation showed 95% (63/66) PV durability and 86% (12/14) PW durability.
Top