BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Recruiting now · Not applicable

Conditions studied: Hypertension, Hypertension, Systolic, Hypertension, Essential

In brief

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.

Key facts

Study ID

NCT06059638

Run by

Orchestra BioMed, Inc

People needed

500

Starts

2023-12-27

Expected to finish

2029-08-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Adventist Health Glendale — Glendale, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• Stanford — Redwood City, California, United States (enrolling)
• Scripps Clinic — San Diego, California, United States (enrolling)
• Sutter Valley Hospitals — San Francisco, California, United States (enrolling)
• South Denver Cardiology — Denver, Colorado, United States (enrolling)
• Colorado Heart and Vascular — Golden, Colorado, United States (enrolling)
• Intermountain Health Lutheran Hospital — Golden, Colorado, United States (enrolling)
• UCHealth Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• HCA Florida JFK Hospital — Atlantis, Florida, United States (enrolling)
• Cardiovascular Research Solutions (MyCardiologist) — Celebration, Florida, United States (enrolling)
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States (enrolling)
• Citrus Cardiology Consultants — Crystal River, Florida, United States (enrolling)
• The Cardiac and Vascular Institute — Gainesville, Florida, United States (enrolling)
• Memorial Healthcare System — Hollywood, Florida, United States (enrolling)
• Baptist Health Jacksonville — Jacksonville, Florida, United States (enrolling)
• Baptist Health South Florida — Miami, Florida, United States (enrolling)
• Mount Sinai Medical Center of Florida — Miami Beach, Florida, United States (enrolling)
• Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
• Piedmont Healthcare, Inc. — Atlanta, Georgia, United States (enrolling)
• Wellstar Research Institute — Marietta, Georgia, United States (enrolling)
• St. Luke's Idaho Cardiology — Boise, Idaho, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• HonorHealth — Scottsdale, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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