BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Last updated: August 15, 2025
Sponsor: Orchestra BioMed, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

High Blood Pressure (Hypertension)

Low Blood Pressure (Hypotension)

Stress

Treatment

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

Clinical Study ID

NCT06059638
CS-08
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performedwithin 30 days prior to a planned implant of a Medtronic Astra/Azure dual-chamberpacemaker system or at any time thereafter

  2. On a stable antihypertension treatment regimen with at least 1 class ofantihypertensive drug

  3. Office SBP ≥135 mmHg and <180 mmHg

  4. Average 24-Hour aSBP ≥130 mmHg and <170 mmHg

Exclusion

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 interventionwithin 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., renaldenervation procedure, baroreflex activation therapy)

  10. Has an existing active cardiac device or neurostimulator other than the recentAstra/Azure pacemaker implant

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Phase:
Study Start date:
December 27, 2023
Estimated Completion Date:
August 31, 2029

Study Description

The study will be conducted in three phases: 1) Screening Phase, 2) Double-blind Randomized Phase (1 year), and 3) Unblinded Phase (2 years). Patients scheduled for implantation of an Astra/Azure pacemaker, or those who already have one implanted, who also have hypertension, may be screened for inclusion into this study. Subjects meeting randomization eligibility criteria will have the investigational AVIM Therapy RAMware downloaded into the Astra/Azure pacemaker and be randomized 1:1 to either have AVIM therapy turned ON or turned OFF. All subjects will continue to receive antihypertensive drug therapy.

Connect with a study center

  • OLV Hospital Aalst

    Aalst,
    Belgium

    Site Not Available

  • OLV Ziekenhuis

    Aalst,
    Belgium

    Active - Recruiting

  • Middelheim Ziekenhuis

    Antwerp,
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussel,
    Belgium

    Active - Recruiting

  • Universite Libre de Bruxelles-Erasme Hospital

    Brussels,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • Institute for Clinical and Experimental Medicine (IKEM)

    Prague,
    Czechia

    Active - Recruiting

  • Na Homolce Hospital

    Prague,
    Czechia

    Active - Recruiting

  • Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus

    Frankfurt,
    Germany

    Active - Recruiting

  • University Medical Centre Mannheim

    Mannheim,
    Germany

    Active - Recruiting

  • Saarland University Hospital

    Saarbrücken,
    Germany

    Active - Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier,
    Germany

    Active - Recruiting

  • Semmelweis University

    Budapest,
    Hungary

    Active - Recruiting

  • University of Debrecen

    Debrecen,
    Hungary

    Active - Recruiting

  • Amsterdam University Medical Centre

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Maastricht UMC+

    Maastricht,
    Netherlands

    Active - Recruiting

  • Jagiellonian University Hospital

    Kraków,
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan,
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw,
    Poland

    Active - Recruiting

  • Silesian Center for Heart Diseases

    Zabrze,
    Poland

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Badalona,
    Spain

    Active - Recruiting

  • Hospital Clínico de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital La Paz

    Madrid,
    Spain

    Site Not Available

  • La Paz University Hospital

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz De Tenerife,
    Spain

    Active - Recruiting

  • Royal Brompton

    London,
    United Kingdom

    Active - Recruiting

  • St. Bartholomew's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St. Thomas Hospital

    London,
    United Kingdom

    Active - Recruiting

  • John Radcliffe Hospital

    Oxford,
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southhampton,
    United Kingdom

    Active - Recruiting

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Stanford

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Sutter Valley Hospitals

    Sacramento, California 95816
    United States

    Site Not Available

  • Scripps Clinic

    San Diego, California 92121
    United States

    Active - Recruiting

  • Sutter Valley Hospitals

    San Francisco, California 94109
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • Citrus Cardiology Consultants

    Crystal River, Florida 34429
    United States

    Active - Recruiting

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Baptist Health Jacksonville

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Baptist Health South Florida

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Mount Sinai Medical Center of Florida

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • West Houston Area Clinical Trial Consultants (Wichita, KS)

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • The Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • St. Elizabeth's Medical Center

    Boston, Massachusetts 02135
    United States

    Active - Recruiting

  • The Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48202-2689
    United States

    Active - Recruiting

  • Michigan Heart

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Health Partners Institute (Methodist Heart and Vascular Center)

    Bloomington, Minnesota 55425
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Washington University St. Louis

    Saint Louis, Missouri 63130
    United States

    Active - Recruiting

  • Washington University St. Louis

    St. Louis, Missouri 63130
    United States

    Site Not Available

  • The Cooper Health System

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Virtua Medical Group, P.A.

    Marlton, New Jersey 08053
    United States

    Active - Recruiting

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Terminated

  • Lovelace Medical Center (New Mexico Heart Institute)

    Albuquerque, New Mexico 87110
    United States

    Active - Recruiting

  • Northwell Health, Inc.

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • WakeMed

    Raleigh, North Carolina 27610
    United States

    Active - Recruiting

  • The Lindner Research Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • OhioHealth Corporation

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma, Oklahoma 73019
    United States

    Site Not Available

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma 73135
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma 73019
    United States

    Active - Recruiting

  • Penn Medicine Lancaster General Health

    Lancaster, Pennsylvania 17602
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Ascension St. Thomas Hospital

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Ascension Seton

    Austin, Texas 78723
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas 75204
    United States

    Active - Recruiting

  • Advocate Aurora Research Institute, LLC

    Milwaukee, Wisconsin 53233
    United States

    Active - Recruiting

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