Home › High Blood Pressure › NCT06059638
BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
Recruiting
Who can join
Ages 18 and older · All sexes
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
About the 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.
What is being tested
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated (device)
- Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated (device)
Sponsor: Orchestra BioMed, Inc · Participants: 316 · Started: Dec 27, 2023
Contact the study team
Official record on ClinicalTrials.gov — NCT06059638
Locations in the U.S.
| Arizona | HonorHealth, Scottsdale |
| California | Adventist Health Glendale, Glendale Hoag Memorial Hospital Presbyterian, Newport Beach Stanford, Redwood City Sutter Valley Hospitals, San Francisco |
| Colorado | South Denver Cardiology, Denver Colorado Heart and Vascular, Golden Intermountain Health Lutheran Hospital, Golden UCHealth Medical Center of the Rockies, Loveland |
| District of Columbia | MedStar Washington Hospital Center, Washington D.C. |
| Florida | HCA Florida JFK Hospital, Atlantis Cardiovascular Research Solutions (MyCardiologist), Celebration Clearwater Cardiovascular Consultants, Clearwater Citrus Cardiology Consultants, Crystal River The Cardiac and Vascular Institute, Gainesville Memorial Healthcare System, Hollywood Sarasota Memorial Hospital, Sarasota |
| Georgia | Piedmont Healthcare, Inc., Atlanta Wellstar Research Institute, Marietta |
| Idaho | St. Luke's Idaho Cardiology, Boise |
| Illinois | University of Chicago, Chicago |
| Kansas | University of Kansas Medical Center, Kansas City Cardiovascular Research Institute of Kansas, Wichita West Houston Area Clinical Trial Consultants (Wichita, KS), Wichita |
| Kentucky | Baptist Health Lexington, Lexington |
| Louisiana | Ochsner Medical Center, New Orleans |
| Maryland | Medstar Union Memorial Hospital, Baltimore The Johns Hopkins University, Baltimore |
| Massachusetts | St. Elizabeth's Medical Center, Boston |
| Michigan | Henry Ford Health, Detroit UMH-Sparrow Clinical Research, Lansing Michigan Heart, Ypsilanti |
| Minnesota | Health Partners Institute (Methodist Heart and Vascular Center), Bloomington Minneapolis Heart Institute, Minneapolis |
| Missouri | Washington University St. Louis, St Louis |
| New Jersey | The Cooper Health System, Camden Hackensack University Medical Center, Hackensack Virtua Medical Group, P.A., Marlton |
| New Mexico | Lovelace Medical Center (New Mexico Heart Institute), Albuquerque |
| New York | Icahn School of Medicine at Mount Sinai, New York University of Rochester - Cardiology CCTU, Rochester |
| North Carolina | HCA Asheville Cardiology Associates, Asheville Atrium Health - Sanger Heart, Charlotte WakeMed, Raleigh |
| Oklahoma | Hightower Clinical Trials, Oklahoma City South Oklahoma Heart Research, Oklahoma City |
| Pennsylvania | Penn Medicine at Doylestown Health Cardiology, Doylestown Hospital of the University of Pennsylvania, Philadelphia |
| South Carolina | Medical University of South Carolina, Charleston |
| Tennessee | Stern Cardiovascular Foundation, Inc., Germantown Ascension St. Thomas Hospital, Nashville |
| Texas | Ascension Seton, Austin Baylor Scott & White Research Institute, Dallas |
| Virginia | Centra Health dba Stroobants Cardiovascular Center, Lynchburg |
| West Virginia | West Virginia University, Morgantown |
| Wisconsin | Advocate Aurora Research Institute, LLC, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.