BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT (BACKBEAT)

May 20, 2026 updated by: Orchestra BioMed, Inc
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Not yet recruiting
        • Lyell McEwin Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Not yet recruiting
        • Alfred Health Hospital
  • Belgium
      • Aalst, Belgium
        • Recruiting
        • OLV Ziekenhuis
      • Antwerp, Belgium
        • Recruiting
        • Middelheim Ziekenhuis
      • Brussels, Belgium
        • Recruiting
        • UZ Brussel
      • Brussels, Belgium
        • Recruiting
        • Universite Libre de Bruxelles-Erasme Hospital
      • Leuven, Belgium
        • Recruiting
        • UZ Leuven
  • Czechia
      • Prague, Czechia
        • Recruiting
        • Na Homolce Hospital
      • Prague, Czechia
        • Recruiting
        • Institute for Clinical and Experimental Medicine (IKEM)
      • Prague, Czechia
        • Recruiting
        • Fakultní nemocnice Královské Vinohrady (FNKV)
  • France
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon (HCL)
      • Nantes, France
        • Recruiting
        • CHU de Nantes
      • Paris, France
        • Recruiting
        • AP-HP Hôpital Pitié Salpêtrière
      • Tours, France
        • Recruiting
        • CHRU Tours
  • Germany
      • Berlin, Germany
        • Recruiting
        • Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)
      • Bonn, Germany
        • Recruiting
        • Herzzentrum Bonn am Universitätsklinikum Bonn
      • Frankfurt, Germany
        • Recruiting
        • Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus
      • Hamburg, Germany
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
      • Leipzig, Germany
        • Not yet recruiting
        • Herzzentrum Leipzig
      • Lübeck, Germany
        • Recruiting
        • University Hospital Luebeck
      • Mannheim, Germany
        • Recruiting
        • University Medical Centre Mannheim
      • Saarbrücken, Germany
        • Recruiting
        • Saarland University Hospital
      • Trier, Germany
        • Recruiting
        • Krankenhaus der Barmherzigen Bruder Trier
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Semmelweis University
      • Budapest, Hungary
        • Recruiting
        • Central Hospital of Northern Pest - Military Hospital
      • Debrecen, Hungary
        • Recruiting
        • University of Debrecen
      • Szeged, Hungary
        • Recruiting
        • University of Szeged
  • Italy
      • Bologna, Italy
        • Recruiting
        • Policlinico Di Sant Orsola Malpighi
      • Milan, Italy
        • Not yet recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
      • Rome, Italy
        • Recruiting
        • Campus Bio-Medico University Hospital
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
      • Verona, Italy
        • Recruiting
        • IRCCS Sacro Cuore Don Calabria
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam University Medical Centre
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht UMC+
      • Zwolle, Netherlands
        • Recruiting
        • Isala Klinieken
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8140
        • Not yet recruiting
        • Christchurch Hospital
  • Poland
      • Katowice, Poland
        • Recruiting
        • Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
      • Krakow, Poland
        • Recruiting
        • Jagiellonian University Hospital
      • Lodz, Poland
        • Not yet recruiting
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
      • Lublin, Poland
        • Recruiting
        • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
      • Poznan, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Szczecin, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny nr 2 PUM
      • Warsaw, Poland
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
      • Wroclaw, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
      • Zabrze, Poland
        • Recruiting
        • Silesian Center for Heart Diseases
  • Spain
      • Badalona, Spain
        • Recruiting
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Recruiting
        • Hospital Clínico de Barcelona
      • Madrid, Spain
        • Recruiting
        • La Paz University Hospital
      • Santa Cruz de Tenerife, Spain
        • Recruiting
        • Hospital Universitario Nuestra Señora de Candelaria
  • Switzerland
      • Basel, Switzerland
        • Recruiting
        • Universitaetsspital Basel
      • Bern, Switzerland
        • Recruiting
        • Universitaetsspital Bern
      • Geneva, Switzerland
        • Recruiting
        • Hôpitaux Universitaires de Genève
      • Lugano, Switzerland
        • Recruiting
        • Cardiocentro Ticino Lugano
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Royal Brompton
      • London, United Kingdom
        • Recruiting
        • St. Bartholomew's Hospital
      • London, United Kingdom
        • Recruiting
        • St. Thomas Hospital
      • Oxford, United Kingdom
        • Recruiting
        • John Radcliffe Hospital
      • Southhampton, United Kingdom
        • Recruiting
        • Southampton General Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • HonorHealth
    • California
      • Glendale, California, United States, 91206
        • Recruiting
        • Adventist Health Glendale
      • Newport Beach, California, United States, 92633
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford
      • San Diego, California, United States, 92121
        • Recruiting
        • Scripps Clinic
      • San Francisco, California, United States, 94109
        • Recruiting
        • Sutter Valley Hospitals
    • Colorado
      • Denver, Colorado, United States, 80210
        • Recruiting
        • South Denver Cardiology
      • Golden, Colorado, United States, 80401
        • Recruiting
        • Intermountain Health Lutheran Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Medstar Washington Hospital Center
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • HCA Florida JFK Hospital
      • Celebration, Florida, United States, 34747
        • Recruiting
        • Cardiovascular Research Solutions (MyCardiologist)
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Clearwater Cardiovascular Consultants
      • Crystal River, Florida, United States, 34429
        • Recruiting
        • Citrus Cardiology Consultants
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • The Cardiac and Vascular Institute
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Healthcare System
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Jacksonville
      • Miami, Florida, United States, 33176
        • Recruiting
        • Baptist Health South Florida
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center of Florida
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Healthcare, Inc.
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Wellstar Research Institute
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • St. Luke's Idaho Cardiology
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • West Houston Area Clinical Trial Consultants (Wichita, KS)
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Medstar Union Memorial Hospital
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • The Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02135
        • Recruiting
        • St. Elizabeth's Medical Center
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • The Brigham and Women's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Recruiting
        • Henry Ford Health
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • UMH-Sparrow Clinical Research
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Michigan Heart
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • Recruiting
        • Health Partners Institute (Methodist Heart and Vascular Center)
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University St. Louis
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • The Cooper Health System
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Medical Group, P.A.
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore University Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • Terminated
        • The Valley Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Lovelace Medical Center (New Mexico Heart Institute)
    • New York
      • New Hyde Park, New York, United States, 11042
        • Withdrawn
        • Northwell Health, Inc.
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
      • Rochester, New York, United States, 14642
        • Not yet recruiting
        • University of Rochester - Cardiology CCTU
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • HCA Asheville Cardiology Associates
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Atrium Health - Sanger Heart
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Lindner Research Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Corporation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Recruiting
        • South Oklahoma Heart Research
      • Oklahoma City, Oklahoma, United States, 73019
        • Recruiting
        • University of Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Recruiting
        • Hightower Clinical Trials
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Recruiting
        • Penn Medicine at Doylestown Health Cardiology
      • Lancaster, Pennsylvania, United States, 17602
        • Recruiting
        • Penn Medicine Lancaster General Health
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Stern Cardiovascular Foundation, Inc.
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Ascension St. Thomas Hospital
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Ascension Seton
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Baylor Scott & White Research Institute
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Centra Health dba Stroobants Cardiovascular Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Advocate Aurora Research Institute, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
AVIM therapy activated with continued stable antihypertensive drug therapy
Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Antihypertensive therapy utilizing atrioventricular interval modulation.
Other Names:
  • BackBeat CNT
Sham Comparator: Control Group
AVIM therapy deactivated with continued stable antihypertensive drug therapy
Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
AVIM therapy is deactivated

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orchestra BioMed, Inc

Collaborators

Medtronic

Investigators

  • Principal Investigator: David Kandzari, MD, Piedmont Heart Institute
  • Principal Investigator: Andrea Russo, MD, Cooper University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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