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New pacemaker technology for treating high blood pressure

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Not applicable Interventional Orchestra BioMed, Inc · NCT06059638

This study is testing a new feature in a Medtronic pacemaker to see if it can help people with high blood pressure feel better while they keep taking their usual medications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorOrchestra BioMed, Inc Industry-sponsored
Locations99 sites (Scottsdale, Arizona and 98 other locations)
Trial IDNCT06059638 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm integrated into a Medtronic Astra/Azure dual-chamber pacemaker. The study consists of three phases: a screening phase, a double-blind randomized phase lasting one year, and an unblinded phase extending over two years. Participants with uncontrolled hypertension who are scheduled for or already have a Medtronic pacemaker will be randomized to receive either active AVIM therapy or a deactivated version while continuing their antihypertensive medications.

Who should consider this trial

Good fit: Ideal candidates include patients with uncontrolled hypertension who are indicated for a dual-chamber pacemaker and are on a stable antihypertensive regimen.

Not a fit: Patients with severe heart failure, recent cardiovascular events, or certain heart valve conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve blood pressure control in patients with hypertension.

How similar studies have performed: Other studies have shown promise with device-based therapies for hypertension, but this specific approach is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamber pacemaker system or at any time thereafter
2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
3. Office SBP ≥135 mmHg and \<180 mmHg
4. Average 24-Hour aSBP ≥130 mmHg and \<170 mmHg

Exclusion Criteria:

1. LVEF \<50%
2. NYHA Class III-IV
3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
4. Myocardial infarction (MI) within 3 months
5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
6. Permanent atrial fibrillation
7. Mitral valve regurgitation greater than or equal to grade 3
8. Aortic stenosis with a valve area less than 1.5 cm2
9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
10. Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Where this trial is running

Scottsdale, Arizona and 98 other locations

+49 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HypertensionHypertension, SystolicHypertension, Essential
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.