Novel Setup Algorithm for Cardiac Neuromodulation Therapy

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

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

Conditions3

Browse More Trials