Ireland
--:--IST
Latest
Clinical Trials in Czechia / NCT05719454
Recruiting Not applicable

Novel Setup Algorithm for Cardiac Neuromodulation Therapy

NCT05719454 · tracked via the Priya Life Science Czechia tracker
Sponsor
BackBeat Medical Inc
Phase
Not applicable
Started
2023-06-21
Last updated
2026-03-09

Condition(s) studied

HypertensionBradycardia

Investigational drug(s) / intervention(s)

CNT testing

CNT testing: The effect of CNT on blood pressure will be obtained throughout the year long follow up period.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 1\. Subject has a known secondary cause of HTN (e.g. renal vascular disease, hyperthyroidism, hyperaldosterone and pheochromocytoma) * 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 an ejection fraction \<50% * Subject has a drop of \> 15% (absolute) in ejection fraction from baseline to week 4 * Subject has symptoms of heart failure, NYHA Class II or greater * 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 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 * Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm * Subject is on dialysis * Subject has estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m² * Subject has significant (\>50% occlusion of left or right carotid artery) carotid artery stenosis * 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 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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Nemocnice Na Homolce (Na Homolce Hospital) Prague Czechia Not Yet Recruiting
Semmelweis University Heart and Vascular Center Budapest Hungary Recruiting
Jagiellonian University Hospital Krakow Poland Not Yet Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu Poznan Poland Not Yet Recruiting
Samodzielny Pub. Szpital Kliniczny nr 2 PUM Szczecin Poland Not Yet Recruiting
Publiczny Centralny Szpital Warsaw Poland Not Yet Recruiting
Silesian Center for Heart Diseases Zabrze Poland Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05719454 on ClinicalTrials.gov ↗ ← All trials in Czechia