Study of Pacemaker with AV Interval Modulation for Blood Pressure Treatment

This study is testing a new feature for Medtronic Astra/Azure pacemakers called atrioventricular interval modulation (AVIM) therapy. This therapy aims to help treat high blood pressure (hypertension). You may be able to join if you have high blood pressure and already have, or are planning to get, a dual-chamber pacemaker. Your office systolic blood pressure (the top number) should be between 135 mmHg and 180 mmHg. The study will see if turning on AVIM therapy in the pacemaker can lower your average 24-hour blood pressure after 3 months, and also check for any serious device-related problems. The study plans to enroll 500 people, but its current status is unclear.

Study design
This is a multinational, randomized, double-blind study. Participants will be assigned by chance to either have the AVIM therapy turned ON or OFF in their pacemaker.
What's involved
You will have your blood pressure measured at the start and at 3 months. The study involves a 1-year double-blind phase and a 2-year unblinded phase.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure will be measured at 3 months after randomization. The study includes a 2-year unblinded phase.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06059638

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Recruiting
NAAges 18+InterventionalTreatment
Orchestra BioMed, Inc
~316 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Medtronic Astra/Azure DR MRI IPG with AVIM therapy ActivatedMedtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

At a glance

Recruiting sites
111 of 131 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months
Measured over Baseline and 3 months post randomization
+1 more outcome measured
Hypertension
Hypertension, Systolic
Hypertension, Essential
131 sites across 44 states
Florida10
Germany9
Poland9
California5
New Jersey5
Belgium5
France5
United Kingdom5
  • David Kandzari, MD · PRINCIPAL_INVESTIGATOR · Piedmont Heart Institute
  • Andrea Russo, MD · PRINCIPAL_INVESTIGATOR · Cooper University

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  • Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 MonthsBaseline and 3 months post randomization

    Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization

  • Freedom from Unanticipated Serious Adverse Device Effects (USADE)3 months post randomization

    Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.