Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06) (CS-06)
Bradycardia, Hypertension, Systolic
About this trial
This is an interventional basic science trial for Bradycardia
Eligibility 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 known Hypertension
- Subject is willing and able to comply with the study and procedures.
Exclusion Criteria:
- Subject has symptoms of heart failure, NYHA Class II or greater
- Subject has significant (>2+) mitral regurgitation, aortic regurgitation or aortic stenosis.
- Subject has permanent atrial fibrillation
- Subject has atrial fibrillation on the day of the study.
- Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
- Subject is on dialysis
- Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke or TIA) at any prior time that has resulted in residual neurologic deficit.
- Subject has a history of autonomic dysfunction
- Women who are pregnant or breast-feeding
- Subject cannot or is unwilling to provide informed consent.
Sites / Locations
- Na Homolce HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Acute CNT pacing signals testing
Acute study procedure will be carried out prior to a pacemaker implantation or replacement: pacemaker Right Atrial (RA) and Right Ventricular (RV) leads will be positioned according to standard procedure for pacemaker implant and connected to a Moderato® System IPG, via a single use, sterile Pacing System Analyzer (PSA) cable. The Moderato IPG will deliver CNT signals. Furthermore, a standard conductance catheter in the left ventricle will measure cardiac volumes and pressure. Arterial blood pressure will be obtained as well. A range of CNT signal parameters will be used to assess the effect on sympathetic activity at different positions of the RV pacing lead while ventricular pressure and volume and arteial pressure signals will be assesed for cardiac function, sympathetic activity and blood pressure. The effects of CNT signal over a range of parameter settings will be studied for the different RV lead positions.