No phaseRecruiting
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT (BACKBEAT)
- Sponsor
- Orchestra BioMed, Inc (Industry)
- Enrolment
- 316 planned
- Conditions
- Hypertension; Hypertension, Systolic; Hypertension, Essential
- Interventions
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated; Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
- Ages
- adults, older adults
- Registry
- NCT06059638
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
- Freedom from Unanticipated Serious Adverse Device Effects (USADE)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered