Recruiting
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure 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.
ClinicalTrials.gov IDNCT06059638
PhaseNA
Enrollment316
SponsorOrchestra BioMed, Inc
Age18 Years
SexALL
Conditions studied
Hypertension, Hypertension, Systolic, Hypertension, Essential
About this study
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.
Interventions
- Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated — Antihypertensive therapy utilizing atrioventricular interval modulation.
- Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated — AVIM therapy is deactivated
Primary outcomes
- Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months (Baseline and 3 months post randomization)
- Freedom from Unanticipated Serious Adverse Device Effects (USADE) (3 months post randomization)
Eligibility information
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
Study locations
- HonorHealth, Scottsdale, Arizona 85258 United States
- Adventist Health Glendale, Glendale, California 91206 United States
- Hoag Memorial Hospital Presbyterian, Newport Beach, California 92633 United States
- Stanford, Redwood City, California 94063 United States
- Scripps Clinic, San Diego, California 92121 United States
- Sutter Valley Hospitals, San Francisco, California 94109 United States
- South Denver Cardiology, Denver, Colorado 80210 United States
- Colorado Heart and Vascular, Golden, Colorado 80401 United States
- Intermountain Health Lutheran Hospital, Golden, Colorado 80401 United States
- UCHealth Medical Center of the Rockies, Loveland, Colorado 80538 United States
Showing 10 of 131 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.