Taking people in CzechiaNo phase

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.

Key facts

Who runs it: BackBeat Medical Inc
Where: Prague, CzechiaSee the siteAlso in 2 other countries, 6 sites
Trial code: NCT05719454
Registry title: Novel Setup Algorithm for Cardiac Neuromodulation Therapy
Status: Recruiting
People taking part: 30 people, planned
Started: 21 Jun 2023
Expected to end: 28 Feb 2028
Type of study: Interventional, 3 groups
Treatments tested: CNT testing
Record updated: 6 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 28 criteriaShow less

Who can take part

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

Who cannot take part

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

Where in Czechia

Also in 2 other countries, 6 sites

Nemocnice Na Homolce (Na Homolce Hospital)Prague, CzechiaContact: Petr Neužil,, Prof.Dr.Taking people

About the trial

What the trial wants to find out

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

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.

The 3 groups in the trial

CNT Setup Algorithm Version 1Treatment being tested
When performing the Setup Algorithm Version 1, each subject's blood pressure is measured with a standard cuff system while the BackBeat-CNT is activated, and system parameters are varied successively according to a specified sequence or based on the blood pressure measurements obtained during previous activations of BackBeat CNT, until the Setup Algorithm is complete. The parameter values as determined by the Setup Algorithm will constitute the programming of the Moderato IPG for the 24 hour activation following setup.
Treatment: CNT testing
CNT Setup Algorithm Version 2Treatment being tested
When performing the Setup Algorithm Version 1, each subject's blood pressure is measured with a standard cuff system while the BackBeat-CNT is activated, and system parameters are varied successively according to a specified sequence or based on the blood pressure measurements obtained during previous activations of BackBeat CNT, until the Setup Algorithm is complete. The parameter values as determined by the Setup Algorithm will constitute the programming of the Moderato IPG for the 24 hour activation following setup.
Treatment: CNT testing
CNT therapy optimization without use of the Setup AlgorithmOther group
For this optimization procedure, each subject's blood pressure is measured with a continuous blood pressure measurement system while the BackBeat-CNT is activated, and system parameters are varied according to a specified sequence until the desired blood pressure reduction is achieved. The parameter values that provide the desired blood pressure reduction will be recorded, for possible use by the investigator following trial completion
Treatment: CNT testing

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?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record

ClinicalTrials.gov NCT05719454

Listed on ClinicalTrials.gov.

Official title

Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals

Plain-language title

Testing a new pacemaker setup method for high blood pressure and slow heartbeatGenerated from the registry record. The registry title is the official one.

AI summary

From the trial's eligibility criteria. Read by machine on 12 November 2026.

Record updated

6 October 2026