New Algorithm for Cardiac Neuromodulation Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nemocnice Na Homolce (Na Homolce Hospital)
  Prague, Czechia Recruiting
• Semmelweis University Heart and Vascular Center
  Budapest, Hungary Recruiting
• Silesian Center for Heart Diseases
  Zabrze, Poland Recruiting
• Jagiellonian University Hospital
  Krakow, Poland Withdrawn
• Uniwersytecki Szpital Kliniczny w Poznaniu
  Poznan, Poland Not yet recruiting
• Samodzielny Pub. Szpital Kliniczny nr 2 PUM
  Szczecin, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.