Novel Setup Algorithm for Cardiac Neuromodulation Therapy

Recruiting now · Not applicable

Conditions studied: Hypertension, Bradycardia

In brief

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.

Key facts

Study ID

NCT05719454

Run by

BackBeat Medical Inc

People needed

30

Starts

2023-06-21

Expected to finish

2028-02-28

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Semmelweis University Heart and Vascular Center — Budapest, Hungary (enrolling)
• Jagiellonian University Hospital — Krakow, Poland
• Nemocnice Na Homolce (Na Homolce Hospital) — Prague, Czechia
• Samodzielny Pub. Szpital Kliniczny nr 2 PUM — Szczecin, Poland
• Publiczny Centralny Szpital — Warsaw, Poland
• Silesian Center for Heart Diseases — Zabrze, Poland
• Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan, Poland

Full record on ClinicalTrials.gov

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