BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

Last updated: March 7, 2025
Sponsor: Orchestra BioMed, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Heart Defect

High Blood Pressure (Hypertension)

Treatment

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated

Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

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 de novo dual chamber pacemaker. Patient informedconsent must be obtained within 30 days prior to a planned de novo implant of aMedtronic Astra/Azure dual chamber pacemaker system or up to 365 days after

  2. On a stable antihypertension treatment regimen with 1, 2, or 3 classes ofantihypertensive drugs

  3. Office SBP ≥140 mmHg and <180 mmHg

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

Exclusion

Exclusion Criteria:

  1. LVEF <50%

  2. NYHA Class II-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. Persistent or permanent atrial fibrillation

  7. Mitral valve regurgitation greater than 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 Activated
Phase:
Study Start date:
December 27, 2023
Estimated Completion Date:
June 30, 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 who are scheduled to undergo implantation of a, or already have an implanted, de novo Astra/Azure pacemaker system, who also have uncontrolled hypertension may be screened for inclusion into this study. All eligible subjects will receive the AVIM RAMware 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

  • University Medical Centre Mannheim

    Mannheim,
    Germany

    Active - Recruiting

  • Semmelweis University

    Budapest,
    Hungary

    Active - Recruiting

  • University of Debrecen

    Debrecen,
    Hungary

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan,
    Poland

    Active - Recruiting

  • Silesian Center for Heart Diseases

    Zabrze,
    Poland

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Badalona,
    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

  • Scripps Clinic

    San Diego, California 92121
    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

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia 30309
    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

  • The Johns Hopkins University

    Baltimore, Maryland 21205
    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

  • 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

    Active - Recruiting

  • Northwell Health, Inc.

    New Hyde Park, New York 11042
    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 City, Oklahoma 73019
    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

  • Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Ascension St. Thomas Hospital

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas 75204
    United States

    Active - Recruiting

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