Could a pacemaker also treat high blood pressure? a new device aims to do both.
NCT ID NCT03757377
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a special pacemaker called the Moderato System in people who need a pacemaker and have high blood pressure that is hard to control with medication. The device is implanted like a regular pacemaker and may help lower blood pressure by adjusting the heart's pacing. About 200 participants will be randomly assigned to have the blood-pressure-lowering feature turned on or off for 12 months, while continuing their usual blood pressure drugs. The study measures whether the device safely reduces average 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 Moderato System (implantable device)
- What this could lead to
- If it works, this device could offer a new way to control blood pressure without extra drugs for people who already need a pacemaker.
- What could go wrong
- This is a mid-stage trial with 203 participants. The device is implanted and carries surgical risks, and the blood-pressure benefit may be modest or not last long-term.
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
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203 people
The number who actually took part.
- Started
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Aug 2017
- Finished
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May 2021
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Requirement of dual chamber pacemaker or upgrade from a single chamber to a dual chamber pacemaker. * Stable (at least 6 weeks) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained without changes. Stable is defined as being in the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks. * Average 24-hour ambulatory systolic blood pressure ≥ 130 mmHg (with directly observed medical therapy, DOT) and office blood pressure ≥140 mmHg. * Subject is able to comply with study visits for at least 13 months (e.g., is capable and willing to travel to/from the center for all scheduled study visits). 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 cardiac arrest. * 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Warsaw, 02-097, Poland
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Silesian Center for Heart Diseases
Zabrze, 41-800, Poland
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UZ Brussel - Heart Rhythm Management Center
Brussels, 1090, Belgium
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Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08661, Lithuania
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