AzTrials
AzTrials

HypertensionBACKBEATNCT06059638

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

A study testing Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated and Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated in people with Hypertension and Hypertension, Systolic, run by Orchestra BioMed, Inc at 131 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated and Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
316 participants
Where
131 sitesin 15 countries
Study dates
27 Dec 2023to Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug
  • Office SBP ≥135 mmHg and <180 mmHg
  • Average 24-Hour aSBP ≥130 mmHg and <170 mmHg

Who cannot join

  • LVEF <50%
  • NYHA Class III-IV
  • History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months
  • Myocardial infarction (MI) within 3 months
  • Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months
  • Permanent atrial fibrillation
Show all 10Show fewer
  • Mitral valve regurgitation greater than or equal to grade 3
  • Aortic stenosis with a valve area less than 1.5 cm2
  • Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)
  • Has an existing active cardiac device or neurostimulator other than the recent Astra/Azure pacemaker implant

Trial locations and contacts

131 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Steven J. Evans, MD contact

917-670-5933

sevans@orchestrabiomed.com

Angela Stagg contact

astagg@orchestrabiomed.com

131 sites in 15 countries

United States72 sites, 16 recruiting

  • Lovelace Medical Center (New Mexico Heart Institute)

    Albuquerque, New Mexico, 87110

    Withdrawn

  • HCA Asheville Cardiology Associates

    Asheville, North Carolina, 28801

    Recruiting

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30309

    Active, not recruiting

  • HCA Florida JFK Hospital

    Atlantis, Florida, 33462

    Active, not recruiting

  • Ascension Seton

    Austin, Texas, 78723

    Active, not recruiting

  • The Johns Hopkins University

    Baltimore, Maryland, 21205

    Recruiting

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218

    Withdrawn

  • Health Partners Institute (Methodist Heart and Vascular Center)

    Bloomington, Minnesota, 55425

    Active, not recruiting

  • St. Luke's Idaho Cardiology

    Boise, Idaho, 83712

    Active, not recruiting

  • The Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Withdrawn

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Withdrawn

  • The Cooper Health System

    Camden, New Jersey, 08103

    Recruiting

  • Cardiovascular Research Solutions (MyCardiologist)

    Celebration, Florida, 34747

    Active, not recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • Atrium Health - Sanger Heart

    Charlotte, North Carolina, 28210

    Active, not recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Recruiting

  • The Lindner Research Center

    Cincinnati, Ohio, 45219

    Withdrawn

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

    Active, not recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Withdrawn

  • OhioHealth Corporation

    Columbus, Ohio, 43214

    Withdrawn

  • Citrus Cardiology Consultants

    Crystal River, Florida, 34429

    Active, not recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204

    Recruiting

  • South Denver Cardiology

    Denver, Colorado, 80210

    Withdrawn

  • Henry Ford Health

    Detroit, Michigan, 48202-2689

    Active, not recruiting

  • Penn Medicine at Doylestown Health Cardiology

    Doylestown, Pennsylvania, 18901

    Withdrawn

  • The Cardiac and Vascular Institute

    Gainesville, Florida, 32605

    Active, not recruiting

  • Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee, 38138

    Active, not recruiting

  • Adventist Health Glendale

    Glendale, California, 91206

    Recruiting

  • Colorado Heart and Vascular

    Golden, Colorado, 80401

    Withdrawn

  • Intermountain Health Lutheran Hospital

    Golden, Colorado, 80401

    Withdrawn

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Active, not recruiting

  • Memorial Healthcare System

    Hollywood, Florida, 33021

    Withdrawn

  • Baptist Health Jacksonville

    Jacksonville, Florida, 32207

    Withdrawn

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Recruiting

  • Penn Medicine Lancaster General Health

    Lancaster, Pennsylvania, 17602

    Withdrawn

  • UMH-Sparrow Clinical Research

    Lansing, Michigan, 48912

    Active, not recruiting

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

    Active, not recruiting

  • UCHealth Medical Center of the Rockies

    Loveland, Colorado, 80538

    Recruiting

  • Centra Health dba Stroobants Cardiovascular Center

    Lynchburg, Virginia, 24501

    Active, not recruiting

  • Wellstar Research Institute

    Marietta, Georgia, 30060

    Active, not recruiting

  • Virtua Medical Group, P.A.

    Marlton, New Jersey, 08053

    Recruiting

  • Baptist Health South Florida

    Miami, Florida, 33176

    Withdrawn

  • Mount Sinai Medical Center of Florida

    Miami Beach, Florida, 33140

    Withdrawn

  • Advocate Aurora Research Institute, LLC

    Milwaukee, Wisconsin, 53233

    Active, not recruiting

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Withdrawn

  • Ascension St. Thomas Hospital

    Nashville, Tennessee, 37203

    Active, not recruiting

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

    Withdrawn

  • Northwell Health, Inc.

    New Hyde Park, New York, 11042

    Withdrawn

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

    Active, not recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92633

    Active, not recruiting

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73019

    Withdrawn

  • Hightower Clinical Trials

    Oklahoma City, Oklahoma, 73102

    Active, not recruiting

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma, 73135

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Active, not recruiting

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

    Withdrawn

  • WakeMed

    Raleigh, North Carolina, 27610

    Withdrawn

  • Stanford

    Redwood City, California, 94063

    Active, not recruiting

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

    Withdrawn

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Withdrawn

  • University of Rochester - Cardiology CCTU

    Rochester, New York, 14642

    Withdrawn

  • Scripps Clinic

    San Diego, California, 92121

    Withdrawn

  • Sutter Valley Hospitals

    San Francisco, California, 94109

    Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

    Active, not recruiting

  • HonorHealth

    Scottsdale, Arizona, 85258

    Active, not recruiting

  • Washington University St. Louis

    St Louis, Missouri, 63130

    Active, not recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Active, not recruiting

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

    Recruiting

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

    Wichita, Kansas, 67226

    Active, not recruiting

  • Michigan Heart

    Ypsilanti, Michigan, 48197

    Active, not recruiting

Other trials in United States

Germany9 sites, 6 recruiting

  • Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)

    Berlin

    Recruiting

  • Herzzentrum Bonn am Universitätsklinikum Bonn

    Bonn

    Withdrawn

  • Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus

    Frankfurt

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

    Withdrawn

  • Herzzentrum Leipzig

    Leipzig

    Recruiting

  • University Hospital Luebeck

    Lübeck

    Recruiting

  • University Medical Centre Mannheim

    Mannheim

    Recruiting

  • Saarland University Hospital

    Saarbrücken

    Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier

    Withdrawn

Other trials in Germany

Poland9 sites, 9 recruiting

  • Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

    Katowice

    Recruiting

  • Jagiellonian University Hospital

    Krakow

    Recruiting

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    Lodz

    Recruiting

  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

    Lublin

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan

    Recruiting

  • Uniwersytecki Szpital Kliniczny nr 2 PUM

    Szczecin

    Recruiting

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw

    Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw

    Recruiting

  • Silesian Center for Heart Diseases

    Zabrze

    Recruiting

Other trials in Poland

Belgium5 sites, 3 recruiting

  • OLV Ziekenhuis

    Aalst

    Withdrawn

  • Middelheim Ziekenhuis

    Antwerp

    Recruiting

  • Universite Libre de Bruxelles-Erasme Hospital

    Brussels

    Recruiting

  • UZ Brussel

    Brussels

    Withdrawn

  • UZ Leuven

    Leuven

    Recruiting

Other trials in Belgium

France5 sites, 5 recruiting

  • CHU Grenoble

    Grenoble

    Recruiting

  • Hospices Civils de Lyon (HCL)

    Lyon

    Recruiting

  • CHU de Nantes

    Nantes

    Recruiting

  • AP-HP Hôpital Pitié Salpêtrière

    Paris

    Recruiting

  • CHRU Tours

    Tours

    Recruiting

Other trials in France

United Kingdom5 sites, 5 recruiting

  • Royal Brompton

    London

    Recruiting

  • St. Bartholomew's Hospital

    London

    Recruiting

  • St. Thomas Hospital

    London

    Recruiting

  • John Radcliffe Hospital

    Oxford

    Recruiting

  • Southampton General Hospital

    Southhampton

    Recruiting

Other trials in United Kingdom

Hungary4 sites, 3 recruiting

  • Central Hospital of Northern Pest - Military Hospital

    Budapest

    Withdrawn

  • Semmelweis University

    Budapest

    Recruiting

  • University of Debrecen

    Debrecen

    Recruiting

  • University of Szeged

    Szeged

    Recruiting

Other trials in Hungary

Italy4 sites, 3 recruiting

  • Policlinico Di Sant Orsola Malpighi

    Bologna

    Withdrawn

  • Campus Bio-Medico University Hospital

    Rome

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona

    Recruiting

  • IRCCS Sacro Cuore Don Calabria

    Verona

    Recruiting

Other trials in Italy

Spain4 sites, 3 recruiting

  • Hospital Germans Trias i Pujol

    Badalona

    Recruiting

  • Hospital Clínico de Barcelona

    Barcelona

    Withdrawn

  • La Paz University Hospital

    Madrid

    Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife

    Recruiting

Other trials in Spain

Switzerland4 sites, 1 recruiting

  • Universitaetsspital Basel

    Basel

    Withdrawn

  • Universitaetsspital Bern

    Bern

    Withdrawn

  • Hôpitaux Universitaires de Genève

    Geneva

    Recruiting

  • Cardiocentro Ticino Lugano

    Lugano

    Withdrawn

Other trials in Switzerland

Czechia3 sites, 3 recruiting

  • Fakultní nemocnice Královské Vinohrady (FNKV)

    Prague

    Recruiting

  • Institute for Clinical and Experimental Medicine (IKEM)

    Prague

    Recruiting

  • Na Homolce Hospital

    Prague

    Recruiting

Other trials in Czechia

Netherlands3 sites, 3 recruiting

  • Amsterdam University Medical Centre

    Amsterdam

    Recruiting

  • Maastricht UMC+

    Maastricht

    Recruiting

  • Isala Klinieken

    Zwolle

    Recruiting

Other trials in Netherlands

China2 sites, 2 recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Recruiting

  • Jiangsu Province Hospital

    Nanjing

    Recruiting

Other trials in China

Australia1 site, 1 recruiting

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

    Recruiting

Other trials in Australia

New Zealand1 site, 1 recruiting

  • ChristChurch Hospital

    Christchurch, Canterbury, 8140

    Recruiting

Other trials in New Zealand

About this study

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.

Read the 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.

Being tested
Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated, Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated
Medical subject headings
Hypertension, Isolated Systolic Hypertension, Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy ActivatedDevice

    Also called BackBeat CNT

    Antihypertensive therapy utilizing atrioventricular interval modulation.

  • Medtronic Astra/Azure DR MRI IPG with AVIM therapy DeactivatedDevice

    AVIM therapy is deactivated

Study groups in NCT06059638
Study groupRoleWhat they receive
Treatment GroupExperimentalAVIM therapy activated with continued stable antihypertensive drug therapy
Receives: Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated
Control GroupSham comparatorAVIM therapy deactivated with continued stable antihypertensive drug therapy
Receives: Device: Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Mean 24-hour ambulatory systolic blood pressure (aSBP) at 3 Months

    Between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) from baseline to 3 months post randomization

    Measured: Baseline and 3 months post randomization

  2. Freedom from Unanticipated Serious Adverse Device Effects (USADE)

    Freedom from Unanticipated Serious Adverse Device Effects (USADE) in the treatment group at 3 months.

    Measured: 3 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start27 Dec 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06059638
Sponsor's protocol ID
CS-08
Acronym
BACKBEAT
Status last verified
Sep 2026
First submitted
22 Sep 2023
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13.

    PubMed 34387126

  • Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Geller L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12):e006974. doi: 10.1161/JAHA.117.006974.

    PubMed 29275370

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Astra/Azure DR MRI IPG with AVIM therapy Activated and Medtronic Astra/Azure DR MRI IPG with AVIM therapy Deactivated in people with Hypertension and Hypertension, Systolic, run by Orchestra BioMed, Inc at 131 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Germany, Poland, Belgium, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Steven J. Evans, MD (917-670-5933, sevans@orchestrabiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06059638, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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