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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

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.

ArizonaHonorHealth, Scottsdale
CaliforniaAdventist Health Glendale, Glendale
Hoag Memorial Hospital Presbyterian, Newport Beach
Stanford, Redwood City
Sutter Valley Hospitals, San Francisco
ColoradoSouth Denver Cardiology, Denver
Colorado Heart and Vascular, Golden
Intermountain Health Lutheran Hospital, Golden
UCHealth Medical Center of the Rockies, Loveland
District of ColumbiaMedStar Washington Hospital Center, Washington D.C.
FloridaHCA 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
GeorgiaPiedmont Healthcare, Inc., Atlanta
Wellstar Research Institute, Marietta
IdahoSt. Luke's Idaho Cardiology, Boise
IllinoisUniversity of Chicago, Chicago
KansasUniversity of Kansas Medical Center, Kansas City
Cardiovascular Research Institute of Kansas, Wichita
West Houston Area Clinical Trial Consultants (Wichita, KS), Wichita
KentuckyBaptist Health Lexington, Lexington
LouisianaOchsner Medical Center, New Orleans
MarylandMedstar Union Memorial Hospital, Baltimore
The Johns Hopkins University, Baltimore
MassachusettsSt. Elizabeth's Medical Center, Boston
MichiganHenry Ford Health, Detroit
UMH-Sparrow Clinical Research, Lansing
Michigan Heart, Ypsilanti
MinnesotaHealth Partners Institute (Methodist Heart and Vascular Center), Bloomington
Minneapolis Heart Institute, Minneapolis
MissouriWashington University St. Louis, St Louis
New JerseyThe Cooper Health System, Camden
Hackensack University Medical Center, Hackensack
Virtua Medical Group, P.A., Marlton
New MexicoLovelace Medical Center (New Mexico Heart Institute), Albuquerque
New YorkIcahn School of Medicine at Mount Sinai, New York
University of Rochester - Cardiology CCTU, Rochester
North CarolinaHCA Asheville Cardiology Associates, Asheville
Atrium Health - Sanger Heart, Charlotte
WakeMed, Raleigh
OklahomaHightower Clinical Trials, Oklahoma City
South Oklahoma Heart Research, Oklahoma City
PennsylvaniaPenn Medicine at Doylestown Health Cardiology, Doylestown
Hospital of the University of Pennsylvania, Philadelphia
South CarolinaMedical University of South Carolina, Charleston
TennesseeStern Cardiovascular Foundation, Inc., Germantown
Ascension St. Thomas Hospital, Nashville
TexasAscension Seton, Austin
Baylor Scott & White Research Institute, Dallas
VirginiaCentra Health dba Stroobants Cardiovascular Center, Lynchburg
West VirginiaWest Virginia University, Morgantown
WisconsinAdvocate 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.