Boston Scientific has completed the first implant in the Navigate X4 safety and efficacy trial, which is evaluating the company’s next generation Acuity X4 left-ventricular pacing leads and Reliance 4-front defibrillation leads.
The multicenter nonrandomized trial will enroll 1,541 and 2,290 adult patients with specific left-ventricular ejection fractions or atrial fibrillation criteria, the devicemaker said Tuesday.
Acuity patients will be measured for lead-related complication-free rates through six months post-implant and for pacing capture thresholds in the programmed configuration at three months post-implant. Reliance patients will be followed for lead-related complication-free rates from three through 24 months following surgery and pacing thresholds at 0.5 ms pulse width at three months.
Both devices are CE-marked, though they remain investigational in the U.S. Results of the Navigate X4 trial will be used to support FDA approval, the company said. — Lena Freund
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