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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.

CaliforniaAdventist Health Glendale, Glendale
Sutter Valley Hospitals, San Francisco
ColoradoUCHealth Medical Center of the Rockies, Loveland
IllinoisUniversity of Chicago, Chicago
KansasUniversity of Kansas Medical Center, Kansas City
Cardiovascular Research Institute of Kansas, Wichita
MarylandThe Johns Hopkins University, Baltimore
MassachusettsSt. Elizabeth's Medical Center, Boston
MinnesotaMinneapolis Heart Institute, Minneapolis
New JerseyThe Cooper Health System, Camden
Virtua Medical Group, P.A., Marlton
New YorkIcahn School of Medicine at Mount Sinai, New York
North CarolinaHCA Asheville Cardiology Associates, Asheville
OklahomaSouth Oklahoma Heart Research, Oklahoma City
South CarolinaMedical University of South Carolina, Charleston
TexasBaylor Scott & White Research Institute, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.