BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

NCT06059638 · tracked via the Priya Life Science USA tracker

Sponsor

Orchestra BioMed, Inc

Phase

Not applicable

Started

2023-12-27

Last updated

2026-08-26

Condition(s) studied

HypertensionHypertension, SystolicHypertension, Essential

Investigational drug(s) / intervention(s)

Medtronic Astra/Azure DR MRI IPG with AVIM therapy ActivatedMedtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated: Antihypertensive therapy utilizing atrioventricular interval modulation.

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated: AVIM therapy is deactivated

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months — Baseline and 3 months post randomization
Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE) — 3 months post randomization
Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.

Trial sites (131)

Facility	City	Region	Status
HonorHealth	Scottsdale	Arizona	Recruiting
Adventist Health Glendale	Glendale	California	Recruiting
Hoag Memorial Hospital Presbyterian	Newport Beach	California	Recruiting
Stanford	Redwood City	California	Recruiting
Scripps Clinic	San Diego	California	Withdrawn
Sutter Valley Hospitals	San Francisco	California	Recruiting
South Denver Cardiology	Denver	Colorado	Recruiting
Colorado Heart and Vascular	Golden	Colorado	Recruiting
Intermountain Health Lutheran Hospital	Golden	Colorado	Recruiting
UCHealth Medical Center of the Rockies	Loveland	Colorado	Recruiting
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	Recruiting
HCA Florida JFK Hospital	Atlantis	Florida	Recruiting
Cardiovascular Research Solutions (MyCardiologist)	Celebration	Florida	Recruiting
Clearwater Cardiovascular Consultants	Clearwater	Florida	Recruiting
Citrus Cardiology Consultants	Crystal River	Florida	Recruiting
The Cardiac and Vascular Institute	Gainesville	Florida	Recruiting
Memorial Healthcare System	Hollywood	Florida	Recruiting
Baptist Health Jacksonville	Jacksonville	Florida	Withdrawn
Baptist Health South Florida	Miami	Florida	Withdrawn
Mount Sinai Medical Center of Florida	Miami Beach	Florida	Withdrawn
Sarasota Memorial Hospital	Sarasota	Florida	Recruiting
Piedmont Healthcare, Inc.	Atlanta	Georgia	Recruiting
Wellstar Research Institute	Marietta	Georgia	Recruiting
St. Luke's Idaho Cardiology	Boise	Idaho	Recruiting
University of Chicago	Chicago	Illinois	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
Cardiovascular Research Institute of Kansas	Wichita	Kansas	Recruiting
West Houston Area Clinical Trial Consultants (Wichita, KS)	Wichita	Kansas	Recruiting
Baptist Health Lexington	Lexington	Kentucky	Recruiting
Ochsner Medical Center	New Orleans	Louisiana	Recruiting
The Johns Hopkins University	Baltimore	Maryland	Recruiting
Medstar Union Memorial Hospital	Baltimore	Maryland	Recruiting
The Brigham and Women's Hospital	Boston	Massachusetts	Withdrawn
St. Elizabeth's Medical Center	Boston	Massachusetts	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Withdrawn
Henry Ford Health	Detroit	Michigan	Recruiting
UMH-Sparrow Clinical Research	Lansing	Michigan	Recruiting
Michigan Heart	Ypsilanti	Michigan	Recruiting
Health Partners Institute (Methodist Heart and Vascular Center)	Bloomington	Minnesota	Recruiting
Minneapolis Heart Institute	Minneapolis	Minnesota	Recruiting

+ 91 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06059638 on ClinicalTrials.gov ↗ ← All trials in the USA