Arrhythmias & electrophysiologyCohort study
Safety and Effectiveness of a Novel Dual-Energy Radiofrequency/Pulsed Field Ablation Catheter: 12 Month Results of the FlexPulse Study
- Prospective single-arm study
- global
- multicentre
Authors' conclusion
In this trial, ablation with TactiFlex Duo in patients with symptomatic, drug-refractory PAF was safe and effective.
Study context
- Population
- Symptomatic, drug-refractory paroxysmal atrial fibrillation (PAF)
- Participants
- 180 participants
- Outcome
- Safety: pre-defined safety events within 7 days of any ablation procedure; effectiveness: freedom from recurrent AF/atrial tachycardia/atrial flutter, repeat procedure, new or escalated class I/III AAD and/or cardioversion
- Follow-up
- 12 months
Main finding
As reported in the abstract
- Recurrent AF/AT/atrial flutter
- Repeat procedure
- New or escalated class I/III AAD and/or cardioversion
Primary effectiveness endpoint
74.6%
Observational data: associations, not effects.
Further findings
Freedom from documented AF/AFL/AT recurrence · 12 months
- Freedom from documented AF/AFL/AT recurrence
- 77.4%
- Without weekly transtelephonic monitoring
- 92.6%
Successful pulmonary vein isolation (PVI)
- Successful PVI achieved in all participants
Additional non-PV ablations
- Subjects with additional non-PV ablations
- 37.2% (67/180)
Durable PV isolation at remapping (15 subjects with repeat ablation after blanking period)
- PVs durably isolated from index procedures
- 79.7% (47/59)
Freedom from AF/AFL/AT with PFA Index ≥30 and AutoMark distance up to 6 mm target workflows · 12 months
- Freedom from AF/AFL/AT
- 84.6%
- retrospective analysis
Safety
Pre-defined safety events within 7 days of any ablation procedure (primary safety endpoint)
- Primary safety endpoint event rate
- 1.7%
Original publication
Summarised from the published abstract; every number is checked against it