Testing a new pacemaker setup method for high blood pressure and slow heartbeat
Tests a pacing device setup for people with high blood pressure and slow heartbeat.
Plain-language title generated from the registry record
Registry title: Novel Setup Algorithm for Cardiac Neuromodulation Therapy
Key facts
- Where
- Budapest, HungarySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high blood pressure who need a dual chamber pacemaker. They test a new setup for BackBeat cardiac neuromodulation therapy (CNT) pacing.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- High blood pressure treated with 1, 2 or 3 stable drugs. Office systolic blood pressure (oSBP) ≥140 and <180 mmHg. At 4 weeks after implant, average 24-hour ambulatory systolic blood pressure (aSBP) ≥130 and <170 mmHg.
- Earlier treatment
- Needs a new or replacement dual chamber pacemaker, or an upgrade from a single chamber one. Blood pressure drugs must have been stable for the prior 1 month and stay unchanged for at least 2 months after implant.
Main reasons for not taking part
- Permanent atrial fibrillation, or paroxysmal atrial fibrillation/flutter with significant burden
- Ejection fraction <50%, or heart failure symptoms NYHA Class II or greater
- Stroke or TIA within 12 months, or heart attack within 3 months
- On dialysis, or estimated GFR <30 ml/min/1.73m²
- Another active cardiac device or neurostimulator, or Type I Diabetes
Read by machine on 9 November 2026.
Where in Hungary
- Semmelweis University - Heart and Vascular CenterBudapest, HungaryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BackBeat Medical Inc
- Trial code
- NCT05719454
- Record updated
- 6 October 2026
- Original description
After meeting all inclusion/exclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume.Read full original descriptionShow less
Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals
After meeting all inclusion/exclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume.
The ambulatory data will provide the basis for a lasting CNT programming by week 8. Follow up visits will be scheduled after 3, 6, and 12 months.
Inclusion: Subject is ≥ 18 years of age; Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker; Subject has stable (for prior 1 month) hypertension treatment with 1, 2 or 3 antihypertensive drugs, which is planned to be maintained without changes for a period of at least 2 months post implant; Subject has an office systolic blood pressure (oSBP) ≥140 and <180 mmHg; At 4 weeks from device implant, subject has an average 24-Hour ambulatory systolic blood pressure (aSBP) ≥130 mmHg and <170 mmHg and an office blood pressure (oSBP) ≥140 and <180 mmHg; Subject is willing and able to comply with study visits and procedures; Subject is willing to adhere to the prescribed baseline antihypertension medical regimen for the duration of the study.
Exclusion: Subject has a history of stroke or TIA within 12 months or any prior stroke with a residual neurological deficit (modified Rankin Score >2+); Subject experienced myocardial infarction (MI) within 3 months prior to enrolment; Subject had a cardiovascular interventional procedure or cardiovascular surgery within 6 months prior to enrolment; 1. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma); Subject has symptoms of heart failure, NYHA Class II or greater; Subject has a history of clinically significant untreated ventricular tachyarrhythmia or has experienced sudden cardiac arrest; Subject has an active device-based treatment for hypertension; Subject has an existing active cardiac device or neurostimulator (e.g., ICD, spinal cord stimulator); Subject has Type I Diabetes; Subject has an ejection fraction <50%; Subject has a drop of > 15% (absolute) in ejection fraction from baseline to week 4; Subject has estimated glomerular filtration rate (GFR) <30 ml/min/1.73m²; Subject has permanent atrial fibrillation; Subject has intermittent paroxysmal atrial fibrillation/flutter with significant burden (i.e., >10% atrial fibrillation/flutter beats if available; Subject has mitral regurgitation ≥2+, aortic stenosis with valve area <1.0 cm2 , or is expected to need a valve repair or replacement; Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm; Subject is on dialysis; Subject has significant (>50% occlusion of left or right carotid artery) carotid artery stenosis; Subject is a member of a vulnerable population (e.g., prisoners, pregnant or lactating women, mentally disabled); Subject has the possibility of becoming pregnant during the conduct of the study and is not willing to use a means of contraception during the study; Subject cannot or is unwilling to provide informed consent.