Study of Medtronic AstraAzure Dual-Chamber Pacemaker Using AV Interval Modulation to Treat High Blood Pressure

What this Trial Is About

Researchers are evaluating a new atrioventricular interval modulation AVIM algorithm designed for dual-chamber Medtronic AstraAzure pacemakers. This multinational, randomized, double-blind clinical trial aims to assess the safety and effectiveness of this AVIM therapy in patients with hypertension who either have or are scheduled to receive these pacemakers. The study is led by Orchestra BioMed, Inc and focuses on managing high blood pressure through this innovative device approach. The trial includes three phases a screening phase, a one-year double-blind randomized phase, and a two-year unblinded phase. Participants who meet eligibility criteria will have the investigational AVIM therapy software downloaded into their AstraAzure pacemaker. They will be randomly assigned to either have the AVIM therapy activated along with their stable antihypertensive drug treatment or have the AVIM therapy deactivated while continuing their usual drug therapy. Participants will be monitored over the course of the study, with the main outcomes measured including changes in 24-hour ambulatory systolic blood pressure at three months and the occurrence of any unanticipated serious adverse device effects. Throughout the study, subjects will continue their antihypertensive medications and undergo regular assessments to evaluate blood pressure control and device safety. The total study duration extends up to five years, allowing for long-term follow-up and evaluation.

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT