Orchestra BioMed has announced that it has surpassed full enrolment in the BACKBEAT global pivotal trial, exceeding its previously announced target of 316 randomised patients.
The BACKBEAT trial is evaluating atrioventricular interval modulation (AVIM) therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of medication.
The trial is being conducted with Medtronic, the company’s strategic collaborator for the BACKBEAT trial and, subject to regulatory approval, for the commercialisation of AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of medication.
As of 30 September 2026, 330 patients have been randomised in the BACKBEAT trial at 81 sites across 13 countries.
The BACKBEAT trial’s protocol, approved by the US Food and Drug Administration (FDA), specifies 284 evaluable randomised subjects for the primary endpoint analysis, with a total enrolment target of 316 patients to account for potential loss to follow-up.
The BACKBEAT trial is a global, multicentre, prospective, randomised, double-blind pivotal trial. Patients are randomised 1:1 to AVIM therapy combined with continued medical therapy and pacing (treatment) or continued medical therapy and standard pacing alone (control).
The primary efficacy endpoint is the between-group difference in the change in 24-hour ambulatory systolic blood pressure (aSBP) at three-month follow-up from pre-randomisation baseline. The primary safety endpoint is freedom from unanticipated serious adverse device events in the AVIM therapy arm at three-month follow-up. The protocol-specified sample size provides greater than 90% statistical power for both primary endpoints and is designed to detect a between-group difference of at least 5mmHg in aSBP.
Vivek Reddy, director of cardiac arrhythmia services at the Mount Sinai Fuster Heart Hospital and director of electrophysiology for the Mount Sinai Health System (New York, USA), executive chairman of the BACKBEAT clinical steering committee, commented: “Randomised, double-blind evidence is the highest standard by which a new therapeutic modality earns its place in clinical practice, and that is exactly what the BACKBEAT trial was designed to generate. The pilot data for AVIM therapy have been exciting, consistent and mechanistically coherent, but the field needs a pivotal trial to answer the question definitively. On behalf of the steering committee, I want to recognise the investigators, coordinators and other professionals whose work enabled the trial to reach full enrolment, and I look forward to seeing the three-month primary endpoint results.”
