New pacemaker technology for treating high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Adventist Health Glendale
  Glendale, California, United States Recruiting
• Sutter Valley Hospitals
  San Francisco, California, United States Recruiting
• UCHealth Medical Center of the Rockies
  Loveland, Colorado, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• Cardiovascular Research Institute of Kansas
  Wichita, Kansas, United States Recruiting

+81 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: David Kandzari, MD — Piedmont Heart Institute
• Study coordinator: Steven J. Evans, MD
• Email: sevans@orchestrabiomed.com
• Phone: 917-670-5933

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.