Stereotaxis has initiated its first prospective, multicentre, randomised clinical study to compare radiofrequency ablation outcomes generated using its Niobe ES remote magnetic navigation system to manual approaches in ischaemic scar ventricular tachycardia (VT) patients.
According to a company release, in 2015 approximately 2,300 of the 60,000 ablation procedures performed in the US to treat VT used the Niobe system.
Researchers from US and European sites will conduct a prospective, post-market, randomised controlled trial involving 382 patients and designed to establish the superiority of VT ablation outcomes using the Niobe ES system versus a manual approach in a low ventricular ejection fraction population. The study, named the “MAGNETIC VT” study, will be led by global principal investigator Andrea Natale, executive medical director, Texas Cardiac Arrhythmia Institute of St David’s Medical Center, along with co-principal investigators Tamas Szili-Torok from Erasmus Medical Center of the Netherlands, and Roderick Tung from The University of Chicago Medicine. Ten hospitals have confirmed participation. The study can be expanded to another five hospitals at the discretion of the study’s sponsor and principal investigators.
Natale and a group of US physicians recently conducted a multicentre, retrospective study comparing long-term success rates with the Niobe system and manual approaches in VT. The findings of that study revealed a substantially greater long-term success rate among the Niobe patient group (81.2% vs. 69%) and were published at the American Heart Association Scientific Sessions.
“Finding the optimal treatment for VT is a very important clinical topic, and the MAGNETIC VT study is one of the few randomised clinical trials being conducted around the world that can lead to meaningful insights on the topic. Through this upcoming study, we have the opportunity to determine if treatment of VT with the Niobe system is superior to manual approaches, which would further support its classification as the standard of care,” says Natale.
“The Niobe system is…well-suited for the treatment of arrhythmias in difficult-to-reach, complex anatomy, such as VT, and has an outstanding performance record in safety, acute success and long-term results with VT ablation,” says William C Mills, Stereotaxis, chief executive officer. “We believe this superiority study will provide definitive evidence of the improved long-term patient outcomes that physicians realise with the Niobe system in treating VT compared to manual approaches.”
Patient enrolment is expected to begin shortly, with follow-up occurring at three, six, nine and twelve months. The primary endpoint is freedom from any recurrence of VT through one year. Participating centres, each considered VT centres of excellence, include:
- Advocate Christ Medical Center (Oak Lawn, IL)
- Algemeen Ziekenhuis (Brugge, Belgium)
- Erasmus Medical Center (Rotterdam, Netherlands)
- Medical College of Georgia (Augusta, GA)
- Intermountain Medical Center (Murray, UT)
- Nemocnice Na Homolce (Prague, Czech Republic)
- Rigshospitalet (Copenhagen, Denmark)
- St. David’s Medical Center (Austin, TX)
- The University of Chicago Medicine (Chicago, IL)
- The University of Kansas Hospital (Kansas City, KS)