BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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
• On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
• Office SBP ≥135 mmHg and <180 mmHg
• Average 24-Hour aSBP ≥130 mmHg and <170 mmHg

🚫 You may not be able to join if…

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

Where this trial is running

• HonorHealth, Scottsdale, Arizona, United States
• Adventist Health Glendale, Glendale, California, United States
• Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
• Stanford, Redwood City, California, United States
• Scripps Clinic, San Diego, California, United States
• Sutter Valley Hospitals, San Francisco, California, United States
• South Denver Cardiology, Denver, Colorado, United States
• Colorado Heart and Vascular, Golden, Colorado, United States
• Intermountain Health Lutheran Hospital, Golden, Colorado, United States
• UCHealth Medical Center of the Rockies, Loveland, Colorado, United States
• MedStar Washington Hospital Center, Washington D.C., District of Columbia, United States
• HCA Florida JFK Hospital, Atlantis, Florida, United States

+ 119 more sites.

Who to contact

Hans-Peter Stoll, MD, PhD · 646-956-2161 · hpstoll@orchestrabiomed.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06059638.