Details

Autor(en) / Beteiligte

• Anter, Elad
• Mansour, Moussa
• Nair, Devi G.
• Sharma, Dinesh
• Taigen, Tyler L.
• Neuzil, Petr
• Kiehl, Erich L.
• Kautzner, Josef
• Osorio, Jose
• Mountantonakis, Stavros
• Natale, Andrea
• Hummel, John D.
• Amin, Anish K.
• Siddiqui, Usman R.
• Harlev, Doron
• Hultz, Paul
• Liu, Shufeng
• Onal, Birce
• Tarakji, Khaldoun G.
• Reddy, Vivek Y.

Titel

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial

Ist Teil von

• Nature medicine, 2024-08, Vol.30 (8), p.2303-2310

Ort / Verlag

New York: Nature Publishing Group US

Erscheinungsjahr

2024

Quelle

MEDLINE

Beschreibungen/Notizen

• Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively ( P  < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm ( P  < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm ( P  < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 . In a randomized trial testing two types of catheter ablation treatments for persistent atrial fibrillation, a large-tip, dual pulsed field and radiofrequency catheter with a large footprint was non-inferior to a conventional radiofrequency catheter.