Recruiting

Bradycardia PacemakerBradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Sponsor:

Orchestra BioMed, Inc

Code:

NCT06059638

Conditions

Hypertension

Hypertension, Systolic

Hypertension, Essential

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Study Details

Brief 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.

Conditions

Hypertension

Hypertension, Systolic

Hypertension, Essential

Study ID

NCT06059638

Start date

Dec 27, 2023

Status verified date

Aug, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

316 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

AVIM therapy activated with continued stable antihypertensive drug therapy

sham comparator: Control Group

AVIM therapy deactivated with continued stable antihypertensive drug therapy

Interventions

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

Primary outcome measure

Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months [ Time Frame: Baseline and 3 months post randomization ]
Freedom from Unanticipated Serious Adverse Device Effects (USADE) [ Time Frame: 3 months post randomization ]

Central Contacts and Locations

Central contacts

Steven J. Evans, MD

917-670-5933 sevans@orchestrabiomed.com

Angela Stagg

astagg@orchestrabiomed.com

Locations

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Adventist Health Glendale

Recruiting

Glendale, California, United States, 91206

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92633

Stanford

Recruiting

Redwood City, California, United States, 94063

Sutter Valley Hospitals

Recruiting

San Francisco, California, United States, 94109

South Denver Cardiology

Recruiting

Denver, Colorado, United States, 80210

Colorado Heart and Vascular

Recruiting

Golden, Colorado, United States, 80401

Intermountain Health Lutheran Hospital

Recruiting

Golden, Colorado, United States, 80401

UCHealth Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

HCA Florida JFK Hospital

Recruiting

Atlantis, Florida, United States, 33462

Cardiovascular Research Solutions (MyCardiologist)

Recruiting

Celebration, Florida, United States, 34747

Clearwater Cardiovascular Consultants

Recruiting

Clearwater, Florida, United States, 33756

Citrus Cardiology Consultants

Recruiting

Crystal River, Florida, United States, 34429

The Cardiac and Vascular Institute

Recruiting

Gainesville, Florida, United States, 32605

Memorial Healthcare System

Recruiting

Hollywood, Florida, United States, 33021

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Piedmont Healthcare, Inc.

Recruiting

Atlanta, Georgia, United States, 30309

Wellstar Research Institute

Recruiting

Marietta, Georgia, United States, 30060

St. Luke's Idaho Cardiology

Recruiting

Boise, Idaho, United States, 83712

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Cardiovascular Research Institute of Kansas

Recruiting

Wichita, Kansas, United States, 67226

West Houston Area Clinical Trial Consultants (Wichita, KS)

Recruiting

Wichita, Kansas, United States, 67226

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Ochsner Medical Center

Recruiting

New Orleans, Louisiana, United States, 70121

The Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Medstar Union Memorial Hospital

Recruiting

Baltimore, Maryland, United States, 21218

St. Elizabeth's Medical Center

Recruiting

Boston, Massachusetts, United States, 02135

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202-2689

UMH-Sparrow Clinical Research

Recruiting

Lansing, Michigan, United States, 48912

Michigan Heart

Recruiting

Ypsilanti, Michigan, United States, 48197

Health Partners Institute (Methodist Heart and Vascular Center)

Recruiting

Bloomington, Minnesota, United States, 55425

Minneapolis Heart Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

Washington University St. Louis

Recruiting

St Louis, Missouri, United States, 63130

The Cooper Health System

Recruiting

Camden, New Jersey, United States, 08103

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Virtua Medical Group, P.A.

Recruiting

Marlton, New Jersey, United States, 08053

Lovelace Medical Center (New Mexico Heart Institute)

Recruiting

Albuquerque, New Mexico, United States, 87110

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

University of Rochester - Cardiology CCTU

Recruiting

Rochester, New York, United States, 14642

HCA Asheville Cardiology Associates

Recruiting

Asheville, North Carolina, United States, 28801

Atrium Health - Sanger Heart

Recruiting

Charlotte, North Carolina, United States, 28210

WakeMed

Recruiting

Raleigh, North Carolina, United States, 27610

Hightower Clinical Trials

Recruiting

Oklahoma City, Oklahoma, United States, 73102

South Oklahoma Heart Research

Recruiting

Oklahoma City, Oklahoma, United States, 73135

Penn Medicine at Doylestown Health Cardiology

Recruiting

Doylestown, Pennsylvania, United States, 18901

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Stern Cardiovascular Foundation, Inc.

Recruiting

Germantown, Tennessee, United States, 38138

Ascension St. Thomas Hospital

Recruiting

Nashville, Tennessee, United States, 37203

Ascension Seton

Recruiting

Austin, Texas, United States, 78723

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75204

Centra Health dba Stroobants Cardiovascular Center

Recruiting

Lynchburg, Virginia, United States, 24501

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Advocate Aurora Research Institute, LLC

Recruiting

Milwaukee, Wisconsin, United States, 53233

More Information

Sponsor

Orchestra BioMed, Inc

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Orchestra BioMed, Inc on 2026-08-26.