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Could a pacemaker tame stubborn high blood pressure?

NCT ID NCT02837445

Disease control Sponsor: BackBeat Medical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This trial tests a special pacemaker-like device, the Moderato System, designed to lower blood pressure in people who have resistant hypertension and already need a dual-chamber pacemaker. Participants are randomly assigned to have the device's blood-pressure-lowering feature turned on or off for six months, while continuing their usual blood pressure medications. The study measures safety and whether the device significantly reduces average systolic blood pressure over 24 hours.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BackBeat Medical Moderato System (implantable pulse generator with PHC therapy)
What this could lead to
If effective, this device could offer a new way to control blood pressure in people who already need a pacemaker, potentially reducing the need for additional medications.
What could go wrong
This is a small, early-stage trial with only 70 participants, so results may not apply to everyone. The device is implanted and carries risks like infection, arrhythmia, or device malfunction.

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

70 people

The number who actually took part.

Started

Jul 2016

Finished

May 2021

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: * Subject requires an implant or replacement a of dual chamber pacemaker * Stable (at least one month) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained for 7 months. * Average day time (7AM-10PM) ambulatory systolic blood pressure ≥ 130 mmHg and office blood pressure ≥140 mmHg. * Subject lives in the proximity of the study center, which permits compliance with study visits for at least 7 months. Exclusion Criteria: * Known secondary cause of HTN. * Average ambulatory or office systolic BP \> 195 mmHg. * Permanent atrial fibrillation. * History of significant paroxysmal atrial fibrillation/flutter burden (defined as \>25% of beats). * Cardiac ejection fraction \<50%. * Symptoms of heart failure, NYHA Class II or greater. * Hypertrophic cardiomyopathy, restrictive cardiomyopathy or inter-ventricular septal thickness ≥ 15 mm. * Subject is on dialysis. * Subject has an estimated Glomerular Filtration Rate \< 30 ml/min/1.73 m² * Prior neurological events (stroke or TIA) within the past year or events at a prior time that has resulted in residual neurologic deficit. * Carotid artery disease. * Known autonomic dysfunction. * History of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden death. * Previous active device-based treatment for HTN. * Existing implant, other than a pacemaker that needs replacing. * Subject is or has the possibility of becoming pregnant and is unwilling of contraception during the study. * Subject is unwilling or cannot provide Informed Consent

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Conditions

The condition(s) this trial relates to.

atrioventricular block Bradycardia Hypertension Resistant to Conventional Therapy hypertensive disorder resistant hypertension

As listed by the trial registrant

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

Atrioventricular block Bradycardia Hypertension, resistant to conventional therapy

Contacts and locations

Locations

  • Krankenhaus der Elisabethinen

    Linz, 4020, Austria

  • Medical University Vienna

    Vienna, 1090, Austria

  • Medical University of Gdansk

    Gdansk, 80-952, Poland

  • Na Homolce Hospital

    Prague, 15030, Czechia

  • P. Stradins Clinical University Hospital

    Riga, 1002, Latvia

  • Pomeranian Medical University Hospital no. 2

    Szczecin, 70-111, Poland

  • Samodzielnym Publicznym Centralnym Szpitalem Klinicznym

    Warsaw, 02-097, Poland

  • Semmelweis University Heart and Vascular Center

    Budapest, 1122, Hungary

  • Silesian Center for Heart Diseases

    Zabrze, 41-800, Poland

  • Szpital Kliniczny Przemiemienia Panskiego

    Poznan, 61-848, Poland

  • UZ Brussel - Heart Rhythm Management Center

    Brussels, 1090, Belgium

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 08661, Lithuania

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