BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Last updated: November 2, 2025
Sponsor: Orchestra BioMed, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

High Blood Pressure (Hypertension - Pediatric)

Arrhythmia

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

    Site Not Available

  • OLV Ziekenhuis

    Aalst 2803448,
    Belgium

    Active - Recruiting

  • Middelheim Ziekenhuis

    Antwerp,
    Belgium

    Site Not Available

  • Middelheim Ziekenhuis

    Antwerp 2803138,
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussel,
    Belgium

    Site Not Available

  • Universite Libre de Bruxelles-Erasme Hospital

    Brussels,
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels 2800866,
    Belgium

    Active - Recruiting

  • Universite Libre de Bruxelles-Erasme Hospital

    Brussels 2800866,
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482,
    Belgium

    Active - Recruiting

  • Institute for Clinical and Experimental Medicine (IKEM)

    Prague,
    Czechia

    Site Not Available

  • Na Homolce Hospital

    Prague,
    Czechia

    Active - Recruiting

  • Institute for Clinical and Experimental Medicine (IKEM)

    Prague 3067696,
    Czechia

    Active - Recruiting

  • Na Homolce Hospital

    Prague 3067696,
    Czechia

    Active - Recruiting

  • Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus

    Frankfurt,
    Germany

    Site Not Available

  • Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus

    Frankfurt 2925536,
    Germany

    Active - Recruiting

  • University Medical Centre Mannheim

    Mannheim,
    Germany

    Site Not Available

  • University Medical Centre Mannheim

    Mannheim 2873891,
    Germany

    Active - Recruiting

  • Saarland University Hospital

    Saarbrücken,
    Germany

    Site Not Available

  • Saarland University Hospital

    Saarbrücken 2842647,
    Germany

    Active - Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier,
    Germany

    Site Not Available

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier 2821164,
    Germany

    Active - Recruiting

  • Semmelweis University

    Budapest,
    Hungary

    Site Not Available

  • Semmelweis University

    Budapest 3054643,
    Hungary

    Active - Recruiting

  • University of Debrecen

    Debrecen,
    Hungary

    Site Not Available

  • University of Debrecen

    Debrecen 721472,
    Hungary

    Active - Recruiting

  • Amsterdam University Medical Centre

    Amsterdam,
    Netherlands

    Site Not Available

  • Amsterdam University Medical Centre

    Amsterdam 2759794,
    Netherlands

    Active - Recruiting

  • Maastricht UMC+

    Maastricht,
    Netherlands

    Site Not Available

  • Maastricht UMC+

    Maastricht 2751283,
    Netherlands

    Active - Recruiting

  • Jagiellonian University Hospital

    Krakow 3094802,
    Poland

    Active - Recruiting

  • Jagiellonian University Hospital

    Kraków,
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan,
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan 3088171,
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw,
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw 756135,
    Poland

    Active - Recruiting

  • Silesian Center for Heart Diseases

    Zabrze,
    Poland

    Site Not Available

  • Silesian Center for Heart Diseases

    Zabrze 3080985,
    Poland

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Badalona,
    Spain

    Site Not Available

  • Hospital Germans Trias i Pujol

    Badalona 3129028,
    Spain

    Active - Recruiting

  • Hospital Clínico de Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clínico de Barcelona

    Barcelona 3128760,
    Spain

    Active - Recruiting

  • Hospital La Paz

    Madrid,
    Spain

    Site Not Available

  • La Paz University Hospital

    Madrid,
    Spain

    Site Not Available

  • La Paz University Hospital

    Madrid 3117735,
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz De Tenerife,
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife 2511174,
    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

    Site Not Available

  • Royal Brompton

    London 2643743,
    United Kingdom

    Active - Recruiting

  • St. Bartholomew's Hospital

    London 2643743,
    United Kingdom

    Active - Recruiting

  • St. Thomas Hospital

    London 2643743,
    United Kingdom

    Active - Recruiting

  • John Radcliffe Hospital

    Oxford,
    United Kingdom

    Site Not Available

  • John Radcliffe Hospital

    Oxford 2640729,
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southhampton,
    United Kingdom

    Active - Recruiting

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • HonorHealth

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Active - Recruiting

  • Stanford

    Redwood City, California 94063
    United States

    Site Not Available

  • Sutter Valley Hospitals

    Sacramento, California 95816
    United States

    Site Not Available

  • Scripps Clinic

    San Diego, California 92121
    United States

    Site Not Available

  • Sutter Valley Hospitals

    San Francisco, California 94109
    United States

    Site Not Available

  • Adventist Health Glendale

    Glendale 5352423, California 5332921 91206
    United States

    Active - Recruiting

  • Stanford

    Redwood City 5386834, California 5332921 94063
    United States

    Active - Recruiting

  • Scripps Clinic

    San Diego 5391811, California 5332921 92121
    United States

    Active - Recruiting

  • Sutter Valley Hospitals

    San Francisco 5391959, California 5332921 94109
    United States

    Active - Recruiting

  • Intermountain Health Lutheran Hospital

    Golden 5423294, Colorado 5417618 80401
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Citrus Cardiology Consultants

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Baptist Health Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Baptist Health South Florida

    Miami, Florida 33176
    United States

    Site Not Available

  • Mount Sinai Medical Center of Florida

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • HCA Florida JFK Hospital

    Atlantis 4146372, Florida 4155751 33462
    United States

    Active - Recruiting

  • Cardiovascular Research Solutions (MyCardiologist)

    Celebration 4150394, Florida 4155751 34747
    United States

    Active - Recruiting

  • Clearwater Cardiovascular Consultants

    Clearwater 4151316, Florida 4155751 33756
    United States

    Active - Recruiting

  • Citrus Cardiology Consultants

    Crystal River 4152487, Florida 4155751 34429
    United States

    Active - Recruiting

  • Memorial Healthcare System

    Hollywood 4158928, Florida 4155751 33021
    United States

    Active - Recruiting

  • Baptist Health Jacksonville

    Jacksonville 4160021, Florida 4155751 32207
    United States

    Active - Recruiting

  • Baptist Health South Florida

    Miami 4164138, Florida 4155751 33176
    United States

    Active - Recruiting

  • Mount Sinai Medical Center of Florida

    Miami Beach 4164143, Florida 4155751 33140
    United States

    Active - Recruiting

  • Sarasota Memorial Hospital

    Sarasota 4172131, Florida 4155751 34239
    United States

    Active - Recruiting

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Piedmont Healthcare, Inc.

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

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

    Wichita, Kansas 67226
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Active - Recruiting

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

    Wichita 4281730, Kansas 4273857 67226
    United States

    Active - Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington 4297983, Kentucky 6254925 40503
    United States

    Active - Recruiting

  • Ochsner Medical Center

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Medical Center

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Active - Recruiting

  • The Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • The Johns Hopkins University

    Baltimore 4347778, Maryland 4361885 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

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • St. Elizabeth's Medical Center

    Boston 4930956, Massachusetts 6254926 02135
    United States

    Active - Recruiting

  • The Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit, Michigan 48202-2689
    United States

    Site Not Available

  • Michigan Heart

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Henry Ford Health

    Detroit 4990729, Michigan 5001836 48202-2689
    United States

    Active - Recruiting

  • UMH-Sparrow Clinical Research

    Lansing 4998830, Michigan 5001836 48912
    United States

    Active - Recruiting

  • Michigan Heart

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Active - Recruiting

  • Health Partners Institute (Methodist Heart and Vascular Center)

    Bloomington, Minnesota 55425
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Health Partners Institute (Methodist Heart and Vascular Center)

    Bloomington 5018739, Minnesota 5037779 55425
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Washington University St. Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Washington University St. Louis

    St. Louis, Missouri 63130
    United States

    Site Not Available

  • Washington University St. Louis

    St Louis 4407066, Missouri 4398678 63130
    United States

    Active - Recruiting

  • The Cooper Health System

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Virtua Medical Group, P.A.

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • The Cooper Health System

    Camden 4501018, New Jersey 5101760 08103
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Virtua Medical Group, P.A.

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Active - Recruiting

  • The Valley Hospital

    Ridgewood 5103269, New Jersey 5101760 07450
    United States

    Terminated

  • Lovelace Medical Center (New Mexico Heart Institute)

    Albuquerque, New Mexico 87110
    United States

    Site Not Available

  • Lovelace Medical Center (New Mexico Heart Institute)

    Albuquerque 5454711, New Mexico 5481136 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

    Site Not Available

  • Northwell Health, Inc.

    New Hyde Park 5128514, New York 5128638 11042
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • WakeMed

    Raleigh, North Carolina 27610
    United States

    Site Not Available

  • HCA Asheville Cardiology Associates

    Asheville 4453066, North Carolina 4482348 28801
    United States

    Active - Recruiting

  • WakeMed

    Raleigh 4487042, North Carolina 4482348 27610
    United States

    Active - Recruiting

  • The Lindner Research Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • OhioHealth Corporation

    Columbus, Ohio 43214
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The Lindner Research Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • OhioHealth Corporation

    Columbus 4509177, Ohio 5165418 43214
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus 4509177, Ohio 5165418 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

    Site Not Available

  • University of Oklahoma

    Oklahoma City, Oklahoma 73019
    United States

    Active - Recruiting

  • Hightower Clinical Trials

    Oklahoma City 4544349, Oklahoma 4544379 73102
    United States

    Active - Recruiting

  • South Oklahoma Heart Research

    Oklahoma City 4544349, Oklahoma 4544379 73135
    United States

    Active - Recruiting

  • University of Oklahoma

    Oklahoma City 4544349, Oklahoma 4544379 73019
    United States

    Active - Recruiting

  • Penn Medicine Lancaster General Health

    Lancaster, Pennsylvania 17602
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Penn Medicine Lancaster General Health

    Lancaster 5197079, Pennsylvania 6254927 17602
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Penn Presbyterian Medical Center

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Ascension St. Thomas Hospital

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Stern Cardiovascular Foundation, Inc.

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Active - Recruiting

  • Ascension St. Thomas Hospital

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Ascension Seton

    Austin, Texas 78723
    United States

    Site Not Available

  • Baylor Scott & White Research Institute

    Dallas, Texas 75204
    United States

    Site Not Available

  • Ascension Seton

    Austin 4671654, Texas 4736286 78723
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute

    Dallas 4684888, Texas 4736286 75204
    United States

    Active - Recruiting

  • Centra Health dba Stroobants Cardiovascular Center

    Lynchburg 4771075, Virginia 6254928 24501
    United States

    Active - Recruiting

  • West Virginia University

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Active - Recruiting

  • Advocate Aurora Research Institute, LLC

    Milwaukee, Wisconsin 53233
    United States

    Site Not Available

  • Advocate Aurora Research Institute, LLC

    Milwaukee 5263045, Wisconsin 5279468 53233
    United States

    Active - Recruiting

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