New Algorithm for Cardiac Neuromodulation Therapy
Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals
This study is testing a new way to set up a heart device to see if it can help people with slow heart rates and high blood pressure feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BackBeat Medical Inc Industry-sponsored |
| Locations | 7 sites (Prague and 6 other locations) |
| Trial ID | NCT05719454 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel setup algorithm for cardiac neuromodulation therapy using the Moderato® Implantable Pulse Generator in patients requiring dual chamber pacemakers. Participants will undergo two setup sessions to test different pacing algorithms after a run-in phase of standard pacing. The study aims to assess the effectiveness of these algorithms in managing hypertension and bradycardia through 24-hour ambulatory blood pressure monitoring. Follow-up visits will occur at 3, 6, and 12 months to evaluate long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require a dual chamber pacemaker and have stable hypertension.
Not a fit: Patients with secondary causes of hypertension or those not requiring pacemaker implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve blood pressure management and overall cardiac function in patients with hypertension and bradycardia.
How similar studies have performed: Previous studies have shown promise with similar pacing approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Prague and 6 other locations
- 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)
Study contacts
- Principal investigator: Béla MERKELY, Prof. MD — Semmelweis University Heart and Vascular Center
- Study coordinator: Linda Korthout
- Email: lkorthout@orchestrabiomed.com
- Phone: +41783482383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.