Rationale and Design of the BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT) Pivotal Trial

Atrioventricular interval modulation (AVIM) is a novel pacing algorithm incorporated into a dual-chamber cardiac pacemaker that enables treatment of hypertension while simultaneously treating bradyarrhythmias. Prior clinical studies have shown that AVIM reduces 24-hour ambulatory systolic blood pressure (aSBP). The BACKBEAT (BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT) pivotal trial is designed toassess the safety and efficacy of AVIM in a prospective, randomized controlled trial. BACKBEAT is a global, multicenter, prospective, randomized, double-blinded clinical trial enrolling approximately 316 subjects across up to 130 sites. Eligible participants include patients implanted with, or scheduled to be implanted with, a dual-chamber pacemaker who have uncontrolled hypertension, defined as office systolic blood pressure (oSBP) ≥135 mmHg and aSBP ≥130 mmHg despite stable medical therapy. All eligible subjects will receive AVIM therapy RAMware downloaded to their device and will be randomized to active treatment (AVIM ON) or control (AVIM OFF), in addition to continued medical therapy. The primary efficacy endpoint is the between-group difference in the change of mean 24-hour aSBP from baseline to 3 months post-randomization. The primary safety endpoint is the proportion of subjects in the treatment group free from unanticipated serious adverse device effects at 3 months. Blinding will continue through 12 months to assess longer-term outcomes. At the end of the 12-month blinded phase, subjects may cross over to the alternate group before entering a 2-year follow-up phase. BACKBEAT will provide rigorous evidence regarding the safety and efficacy of AVIM therapy for hypertension in patients with a dual-chamber pacemaker.