OBJECTIVES: This first-in-human feasibility study was undertaken to translate the novel low-voltage MultiPulse Therapy (MPT) (Cardialen, Inc., Minneapolis, Minnesota), which was previously been shown to be effective in preclinical studies in terminating atrial fibrillation (AF), into clinical use. BACKGROUND: Current treatment options for AF, the most common arrhythmia in clinical practice, have limited success. Previous attempts at treating AF by using implantable devices have been limited by the painful nature of high-voltage shocks. METHODS: Forty-two patients undergoing AF ablation were recruited at 6 investigational centers worldwide. Before ablation, electrode catheters were placed in the coronary sinus, right and/or left atrium, for recording and stimulation. After the induction of AF, MPT, which consists of up to a 3-stage sequence of far- and near-field stimulation pulses of varied amplitude, duration, and interpulse timing, was delivered via temporary intracardiac leads. MPT parameters and delivery methods were iteratively optimized. RESULTS: In the 14 patients from the efficacy phase, MPT terminated 37 of 52 (71%) of AF episodes, with the lowest median energy of 0.36 J (interquartile range [IQR]: 0.14 to 1.21 J) and voltage of 42.5 V (IQR: 25 to 75 V). Overall, 38% of AF terminations occurred within 2 seconds of MPT delivery (p < 0.0001). Shorter time between AF induction and MPT predicted success of MPT in terminating AF (p < 0.001). CONCLUSIONS: MPT effectively terminated AF at voltages and energies known to be well tolerated or painless in some patients. Our results support further studies of the concept of implanted devices for early AF conversion to reduce AF burden, symptoms, and progression.

Cardialen Inc Minneapolis Minnesota USA

George Washington University Washington DC USA

Hôpital Cardiologique du Haut Lévêque Bordeaux Pessac Bordeaux France

Institut Klinické a Experimentální Medicíny Prague Czech Republic

Mount Sinai School of Medicine New York New York USA

Na Homolce Prague Czech Republic

National Heart and Lung Institute Imperial College London London United Kingdom; Imperial College Healthcare NHS Trust London United Kingdom

National Heart and Lung Institute Imperial College London London United Kingdom; Imperial College Healthcare NHS Trust London United Kingdom; Chelsea and Westminster Hospital NHS Foundation Trust London United Kingdom

Sequoia Hospital Redwood City California USA

University Hospital Brno Brno Czech Republic

JACC Clin Electrophysiol. 2021 Aug;7(8):1000-1002. doi: 10.1016/j.jacep.2021.01.012. PubMed

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