BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
- Hypertension
- Hypertension, Systolic
- Hypertension, Essential
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Orchestra BioMed, Inc
- Enrolment target
- 316
- Started
- 27 December 2023
- Main results due
- December 2026
- Study sites
- 131
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(131)
HonorHealth
Scottsdale, Arizona, United States
Recruiting
Adventist Health Glendale
Glendale, California, United States
Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Recruiting
Stanford
Redwood City, California, United States
Recruiting
Scripps Clinic
San Diego, California, United States
Withdrawn
Sutter Valley Hospitals
San Francisco, California, United States
Recruiting
South Denver Cardiology
Denver, Colorado, United States
Recruiting
Colorado Heart and Vascular
Golden, Colorado, United States
Recruiting
Intermountain Health Lutheran Hospital
Golden, Colorado, United States
Recruiting
UCHealth Medical Center of the Rockies
Loveland, Colorado, United States
Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Recruiting
HCA Florida JFK Hospital
Atlantis, Florida, United States
Recruiting
Cardiovascular Research Solutions (MyCardiologist)
Celebration, Florida, United States
Recruiting
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Recruiting
Citrus Cardiology Consultants
Crystal River, Florida, United States
Recruiting
The Cardiac and Vascular Institute
Gainesville, Florida, United States
Recruiting
Memorial Healthcare System
Hollywood, Florida, United States
Recruiting
Baptist Health Jacksonville
Jacksonville, Florida, United States
Withdrawn
Baptist Health South Florida
Miami, Florida, United States
Withdrawn
Mount Sinai Medical Center of Florida
Miami Beach, Florida, United States
Withdrawn
Sarasota Memorial Hospital
Sarasota, Florida, United States
Recruiting
Piedmont Healthcare, Inc.
Atlanta, Georgia, United States
Recruiting
Wellstar Research Institute
Marietta, Georgia, United States
Recruiting
St. Luke's Idaho Cardiology
Boise, Idaho, 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
West Houston Area Clinical Trial Consultants (Wichita, KS)
Wichita, Kansas, United States
Recruiting
Baptist Health Lexington
Lexington, Kentucky, United States
Recruiting
Ochsner Medical Center
New Orleans, Louisiana, United States
Recruiting
The Johns Hopkins University
Baltimore, Maryland, United States
Recruiting
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
Recruiting
The Brigham and Women's Hospital
Boston, Massachusetts, United States
Withdrawn
St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Withdrawn
Henry Ford Health
Detroit, Michigan, United States
Recruiting
UMH-Sparrow Clinical Research
Lansing, Michigan, United States
Recruiting
Michigan Heart
Ypsilanti, Michigan, United States
Recruiting
Health Partners Institute (Methodist Heart and Vascular Center)
Bloomington, Minnesota, United States
Recruiting
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Withdrawn
Washington University St. Louis
St Louis, Missouri, United States
Recruiting
The Cooper Health System
Camden, New Jersey, United States
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Virtua Medical Group, P.A.
Marlton, New Jersey, United States
Recruiting
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Withdrawn
The Valley Hospital
Ridgewood, New Jersey, United States
Withdrawn
Lovelace Medical Center (New Mexico Heart Institute)
Albuquerque, New Mexico, United States
Recruiting
Northwell Health, Inc.
New Hyde Park, New York, United States
Withdrawn
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Recruiting
University of Rochester - Cardiology CCTU
Rochester, New York, United States
Recruiting
HCA Asheville Cardiology Associates
Asheville, North Carolina, United States
Recruiting
Atrium Health - Sanger Heart
Charlotte, North Carolina, United States
Recruiting
WakeMed
Raleigh, North Carolina, United States
Recruiting
The Lindner Research Center
Cincinnati, Ohio, United States
Withdrawn
The Ohio State University
Columbus, Ohio, United States
Withdrawn
OhioHealth Corporation
Columbus, Ohio, United States
Withdrawn
University of Oklahoma
Oklahoma City, Oklahoma, United States
Withdrawn
Hightower Clinical Trials
Oklahoma City, Oklahoma, United States
Recruiting
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
Recruiting
Showing 60 of 131 sites — filter to narrow it down. 104 of the 131 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06059638. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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