An interventional study of Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated and Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated in Hypertension, Hypertension, Systolic and Hypertension, Essential, sponsored by Orchestra BioMed, Inc. Recruiting at 131 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Orchestra BioMed, Inc · Not applicable, Interventional, and Treatment
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.
The study will be conducted in three phases: 1) Screening Phase, 2) Double-blind Randomized Phase (1 year), and 3) Unblinded Phase (2 years). Patients scheduled for implantation of an Astra/Azure pacemaker, or those who already have one implanted, who also have hypertension, may be screened for inclusion into this study. Subjects meeting randomization eligibility criteria will have the investigational AVIM Therapy RAMware downloaded into the Astra/Azure pacemaker and be randomized 1:1 to either have AVIM therapy turned ON or turned OFF. All subjects will continue to receive antihypertensive drug therapy.
Exclusion Criteria:
AVIM therapy activated with continued stable antihypertensive drug therapy
Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
AVIM therapy deactivated with continued stable antihypertensive drug therapy
Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Antihypertensive therapy utilizing atrioventricular interval modulation.
Also known as: BackBeat CNT
AVIM therapy is deactivated
Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Time frame: Baseline and 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE)
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.
Time frame: 3 months post randomization
Showing the first 100 of 131 sites across 15 countries.
Plan to share: No
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Orchestra BioMed, Inc