Three-Month Data from the Moderato-HTN Trial Published
American Heart Association Journal
3-months data from Moderato-HTN first-in-human clinical study was published in the American Heart Association Journal. The study was an open-label, single-arm, multicenter, prospective trial investigating the safety and efficacy of BackBeat PHC pacing therapy in patients with persistent hypertension indicated for implantation or replacement of a dual-chamber pacemaker.
Twenty seven (27) patients with persistent oSBP>140 mmHg after 1-month of conventional pacing were included in the study. Compared with pre-PHC therapy activation measurements, office systolic blood pressure decreased by 16 mmHg at 3 months, which corresponded to a 24 mmHg drop from baseline values. No device-related serious adverse effects were noted. The paper concluded that initial indications are that this therapy is a safe and promising therapy for pacemaker patients with persistent hypertension.