Johnson & Johnson MedTech has released 12-month results from its SmartfIRE clinical trial, demonstrating an 86.9% efficacy rate for its ThermoCool SmartTouch SF catheter in patients adhering to recommended ablation parameters. The findings, presented at the EHRA annual meeting, also showed reduced antiarrhythmic drug use, improved patient outcomes, and lower healthcare utilization.
The catheter integrates with J&J’s TruPulse generator and Carto 3 mapping system, marking the first dual-energy pulsed field (PF) and radiofrequency (RF) ablation catheter with an ablation index. With a CE mark granted in late 2024, it remains investigational in the U.S.
Key results:
- 86.9% efficacy with high adherence to protocol
- 71.5% freedom from recurrence at 12 months
- 40.8% reduction in CV-related hospitalizations
- 3.6% serious adverse effects, none related to PF energy
J&J also presented real-world findings from its REAL AF registry, investigating catheter ablation safety, gender differences in outcomes, and zero-fluoroscopy approaches. Additionally, the company launched the GPfIRE study to evaluate PF energy’s impact on vagal modulation after pulmonary vein isolation.
“By supporting studies like GPfIRE, we are committed to generating robust clinical evidence that not only informs treatment decisions but also drives innovation in AFib care,” said Jennifer Currin, VP of Scientific Affairs.
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