Clinical Trial

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Study acronym: BACKBEAT
Recruiting
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Summary
A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
Protocol Amendment History 1 change
notable Trial sites expanded: 99 -> 128 locations 2026-05-23
Trial Details
NCT Number NCT06059638
Lead Sponsor Orchestra BioMed, Inc
Collaborators: Medtronic
Conditions Hypertension, Hypertension, Systolic, Hypertension, Essential
Enrollment 500 participants
Start Date 2023-12-27
Primary Completion 2026-12 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-09