The pivotal SYMPLICITY HTN-3 clinical trial designed to evaluate the safety and efficacy of renal denervation as a treatment for uncontrolled hypertension failed to meet its primary efficacy endpoint.
Patients enrolled in the trial were randomized to treatment of bilateral renal denervation using Medtronic’s SYMPLICITY catheter system and generator or to a masked procedure. The primary outcome was change in systolic blood pressure at six months from baseline based on readings in an office setting.
Minneapolis-based Medtronic, sponsor of the trial, reported that the trial failed to meet its primary efficacy endpoint. The study did meet its primary safety endpoint, which was incidence of major adverse events one month after the procedure.
It will continue to follow the trial’s 535 participants for five years.
Medtronic said it would assemble a panel of independent advisers to determine next steps. Those recommendations may include suspending enrollment in the international SYMPLICITY-4 trial, which was designed to provide evidence for regulatory approval in the U.S.