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Pacemaker tweak may lower blood pressure without extra pills

NCT ID NCT06059638

Disease control Sponsor: Orchestra BioMed, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This study tests a special pacemaker setting designed to lower blood pressure in people with hypertension. About 500 adults who already have or need a pacemaker will take part. The goal is to see if this new setting safely reduces average blood pressure over 24 hours, compared to standard pacing.

Why investors are watching

Orchestra BioMed is running a 316-patient trial that tests whether a software change in a standard Medtronic pacemaker can lower blood pressure. For a micro-cap company with few other products, this readout could determine whether its main technology works and whether it has a viable business.

If it works: A positive result could validate the company's approach and make its technology attractive to a larger partner or buyer. That could give the company a path to revenue without needing to build its own sales force.

If it fails: Trials fail often, and a negative or delayed result could leave the company without a clear product. Because the company is very small, a setback in this single study could put its future in question.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 316 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

essential hypertension essential hypertension, genetic hypertensive disorder Isolated Systolic Hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension Hypertension, systolic Hypertension,essential

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    113 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HP Hôpital Pitié Salpêtrière

    RECRUITING

    Paris, France

  • Adventist Health Glendale

    RECRUITING

    Glendale, California, 91206, United States

  • Advocate Aurora Research Institute, LLC

    RECRUITING

    Milwaukee, Wisconsin, 53233, United States

  • Amsterdam University Medical Centre

    RECRUITING

    Amsterdam, Netherlands

  • Ascension Seton

    RECRUITING

    Austin, Texas, 78723, United States

  • Ascension St. Thomas Hospital

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Atrium Health - Sanger Heart

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • Azienda Ospedaliera Universitaria Integrata Verona

    RECRUITING

    Verona, Italy

  • Baptist Health Jacksonville

    WITHDRAWN

    Jacksonville, Florida, 32207, United States

  • Baptist Health Lexington

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Baptist Health South Florida

    WITHDRAWN

    Miami, Florida, 33176, United States

  • Baylor Scott & White Research Institute

    RECRUITING

    Dallas, Texas, 75204, United States

  • Beth Israel Deaconess Medical Center

    WITHDRAWN

    Boston, Massachusetts, 02215, United States

  • CHRU Tours

    RECRUITING

    Tours, France

  • CHU Grenoble

    RECRUITING

    Grenoble, France

  • CHU de Nantes

    RECRUITING

    Nantes, France

  • Campus Bio-Medico University Hospital

    RECRUITING

    Rome, Italy

  • Cardioangiologisches Centrum Bethanien (CCB) am AGAPLESION Markus Krankenhaus

    RECRUITING

    Frankfurt, Germany

  • Cardiocentro Ticino Lugano

    RECRUITING

    Lugano, Switzerland

  • Cardiovascular Research Institute of Kansas

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Cardiovascular Research Solutions (MyCardiologist)

    RECRUITING

    Celebration, Florida, 34747, United States

  • Centra Health dba Stroobants Cardiovascular Center

    RECRUITING

    Lynchburg, Virginia, 24501, United States

  • Central Hospital of Northern Pest - Military Hospital

    RECRUITING

    Budapest, Hungary

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    NOT_YET_RECRUITING

    Lodz, Poland

  • ChristChurch Hospital

    RECRUITING

    Christchurch, Canterbury, 8140, New Zealand

  • Citrus Cardiology Consultants

    RECRUITING

    Crystal River, Florida, 34429, United States

  • Clearwater Cardiovascular Consultants

    RECRUITING

    Clearwater, Florida, 33756, United States

  • Colorado Heart and Vascular

    RECRUITING

    Golden, Colorado, 80401, United States

  • Fakultní nemocnice Královské Vinohrady (FNKV)

    RECRUITING

    Prague, Czechia

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

    RECRUITING

    Katowice, Poland

  • HCA Asheville Cardiology Associates

    RECRUITING

    Asheville, North Carolina, 28801, United States

  • HCA Florida JFK Hospital

    RECRUITING

    Atlantis, Florida, 33462, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Health Partners Institute (Methodist Heart and Vascular Center)

    RECRUITING

    Bloomington, Minnesota, 55425, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202-2689, United States

  • Herzzentrum Bonn am Universitätsklinikum Bonn

    RECRUITING

    Bonn, Germany

  • Herzzentrum Leipzig

    NOT_YET_RECRUITING

    Leipzig, Germany

  • Hightower Clinical Trials

    RECRUITING

    Oklahoma City, Oklahoma, 73102, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92633, United States

  • HonorHealth

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Hospices Civils de Lyon (HCL)

    RECRUITING

    Lyon, France

  • Hospital Clínico de Barcelona

    RECRUITING

    Barcelona, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    RECRUITING

    Santa Cruz de Tenerife, Spain

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Hôpitaux Universitaires de Genève

    RECRUITING

    Geneva, Switzerland

  • IRCCS Sacro Cuore Don Calabria

    RECRUITING

    Verona, Italy

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Institute for Clinical and Experimental Medicine (IKEM)

    RECRUITING

    Prague, Czechia

  • Intermountain Health Lutheran Hospital

    RECRUITING

    Golden, Colorado, 80401, United States

  • Isala Klinieken

    RECRUITING

    Zwolle, Netherlands

  • Jagiellonian University Hospital

    RECRUITING

    Krakow, Poland

  • Jersey Shore University Medical Center

    WITHDRAWN

    Neptune City, New Jersey, 07753, United States

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, China

  • John Radcliffe Hospital

    RECRUITING

    Oxford, United Kingdom

  • Krankenhaus der Barmherzigen Brüder Trier

    RECRUITING

    Trier, Germany

  • La Paz University Hospital

    RECRUITING

    Madrid, Spain

  • Lovelace Medical Center (New Mexico Heart Institute)

    RECRUITING

    Albuquerque, New Mexico, 87110, United States

  • Lyell McEwin Hospital

    RECRUITING

    Elizabeth Vale, South Australia, 5112, Australia

  • Maastricht UMC+

    RECRUITING

    Maastricht, Netherlands

  • Mayo Clinic

    WITHDRAWN

    Rochester, Minnesota, 55905, United States

  • MedStar Washington Hospital Center

    RECRUITING

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

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medstar Union Memorial Hospital

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Memorial Healthcare System

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Michigan Heart

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Middelheim Ziekenhuis

    RECRUITING

    Antwerp, Belgium

  • Minneapolis Heart Institute

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Mount Sinai Medical Center of Florida

    WITHDRAWN

    Miami Beach, Florida, 33140, United States

  • Na Homolce Hospital

    RECRUITING

    Prague, Czechia

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Northwell Health, Inc.

    WITHDRAWN

    New Hyde Park, New York, 11042, United States

  • OLV Ziekenhuis

    WITHDRAWN

    Aalst, Belgium

  • Ochsner Medical Center

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • OhioHealth Corporation

    WITHDRAWN

    Columbus, Ohio, 43214, United States

  • Penn Medicine Lancaster General Health

    WITHDRAWN

    Lancaster, Pennsylvania, 17602, United States

  • Penn Medicine at Doylestown Health Cardiology

    RECRUITING

    Doylestown, Pennsylvania, 18901, United States

  • Penn Presbyterian Medical Center

    WITHDRAWN

    Philadelphia, Pennsylvania, 19104, United States

  • Piedmont Healthcare, Inc.

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Policlinico Di Sant Orsola Malpighi

    RECRUITING

    Bologna, Italy

  • Royal Brompton

    RECRUITING

    London, United Kingdom

  • Saarland University Hospital

    RECRUITING

    Saarbrücken, Germany

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Scripps Clinic

    WITHDRAWN

    San Diego, California, 92121, United States

  • Semmelweis University

    RECRUITING

    Budapest, Hungary

  • Silesian Center for Heart Diseases

    RECRUITING

    Zabrze, Poland

  • South Denver Cardiology

    RECRUITING

    Denver, Colorado, 80210, United States

  • South Oklahoma Heart Research

    RECRUITING

    Oklahoma City, Oklahoma, 73135, United States

  • Southampton General Hospital

    RECRUITING

    Southhampton, United Kingdom

  • St. Bartholomew's Hospital

    RECRUITING

    London, United Kingdom

  • St. Elizabeth's Medical Center

    RECRUITING

    Boston, Massachusetts, 02135, United States

  • St. Luke's Idaho Cardiology

    RECRUITING

    Boise, Idaho, 83712, United States

  • St. Thomas Hospital

    RECRUITING

    London, United Kingdom

  • Stanford

    RECRUITING

    Redwood City, California, 94063, United States

  • Stern Cardiovascular Foundation, Inc.

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Sutter Valley Hospitals

    RECRUITING

    San Francisco, California, 94109, United States

  • The Brigham and Women's Hospital

    WITHDRAWN

    Boston, Massachusetts, 02115, United States

  • The Cardiac and Vascular Institute

    RECRUITING

    Gainesville, Florida, 32605, United States

  • The Cooper Health System

    RECRUITING

    Camden, New Jersey, 08103, United States

  • The Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • The Lindner Research Center

    WITHDRAWN

    Cincinnati, Ohio, 45219, United States

  • The Ohio State University

    WITHDRAWN

    Columbus, Ohio, 43210, United States

  • The Valley Hospital

    WITHDRAWN

    Ridgewood, New Jersey, 07450, United States

  • UCHealth Medical Center of the Rockies

    RECRUITING

    Loveland, Colorado, 80538, United States

  • UMH-Sparrow Clinical Research

    RECRUITING

    Lansing, Michigan, 48912, United States

  • UZ Brussel

    WITHDRAWN

    Brussels, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, Belgium

  • Universitaetsspital Basel

    RECRUITING

    Basel, Switzerland

  • Universitaetsspital Bern

    RECRUITING

    Bern, Switzerland

  • Universite Libre de Bruxelles-Erasme Hospital

    RECRUITING

    Brussels, Belgium

  • University Hospital Luebeck

    RECRUITING

    Lübeck, Germany

  • University Medical Centre Mannheim

    RECRUITING

    Mannheim, Germany

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Debrecen

    RECRUITING

    Debrecen, Hungary

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Oklahoma

    WITHDRAWN

    Oklahoma City, Oklahoma, 73019, United States

  • University of Rochester - Cardiology CCTU

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Szeged

    RECRUITING

    Szeged, Hungary

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité (DHZC)

    RECRUITING

    Berlin, Germany

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

    RECRUITING

    Wroclaw, Poland

  • Uniwersytecki Szpital Kliniczny nr 2 PUM

    RECRUITING

    Szczecin, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, Poland

  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    RECRUITING

    Warsaw, Poland

  • Virtua Medical Group, P.A.

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • WakeMed

    RECRUITING

    Raleigh, North Carolina, 27610, United States

  • Washington University St. Louis

    RECRUITING

    St Louis, Missouri, 63130, United States

  • Wellstar Research Institute

    RECRUITING

    Marietta, Georgia, 30060, United States

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

    RECRUITING

    Wichita, Kansas, 67226, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

    RECRUITING

    Lublin, Poland

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