Bradycardia, Hypertension, Systolic
Conditions
Brief summary
This investigation will evaluate the effect of RV pacing lead position on cardiac function and the modulation of the autonomic nervous system with Cardiac Neuromodulation Therapy (CNT) pacing signals. The study will be performed acutely prior to a pacemaker implant.
Detailed description
Subjects indicated for a dual chamber pacemaker implant or replacement who are not 100% dependent on right ventricular pacing may be eligible to participate in the study. This investigation will evaluate the effect of RV pacing lead position on cardiac function and the modulation of the autonomic nervous system using Cardiac Neuromodulation Therapy (CNT) pacing signals at different positions of the RV pacing lead. A standard conductance catheter will be introduced through the femoral artery and advanced into the left ventricle to measure cardiac volumes and pressure. Arterial blood pressure will be measured from the other femoral artery with an additional sheath. The Moderato® IPG will be used to generate Cardiac Neuromodulation Therapy (CNT) signals and deliver them to the patient through the cable and leads. A range of CNT signal parameters will be used to assess the effect on sympathetic activity at different positions of the RV pacing lead. Ventricular pressure and volume readings from the conductance catheter and arterial pressure readings will be recorded and analyzed to assess the effect of CNT signals on 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.
Interventions
DEVICEModerato IPG's CNT pacing signals
Assesment of cardiac function and sympatheric activity will be obtained simultaneously
DEVICECD Leycom Pressure/Volume Combination Catheters
Simultaneous recording of the Pressure, Volume measurements and ECG signals will be done for constant monitoring of intra-ventricular pressure and volume.
Sponsors
BackBeat Medical Inc
CD Leycom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is ≥ 18 years of age 2. Subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker 3. Subject has known Hypertension 4. Subject is willing and able to comply with the study and procedures.
Exclusion criteria
1. Subject has symptoms of heart failure, NYHA Class II or greater 2. Subject has significant (\>2+) mitral regurgitation, aortic regurgitation or aortic stenosis. 3. Subject has permanent atrial fibrillation 4. Subject has atrial fibrillation on the day of the study. 5. Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm 6. Subject is on dialysis 7. 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. 8. Subject has a history of autonomic dysfunction 9. Women who are pregnant or breast-feeding 10. Subject cannot or is unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of the Moderato CNT pacing signals on cardiac function | approximately one hour | Left ventricular pressure (mmHg) and Volume (ml) will be obtained by a multisensor catheter which provides real-time, beat-to-beat intra-ventricular measurement of cardiac function and performance. Data will be used to generate Pressure-Volume Loops, an aknowledged way to describe hemodynamic changes. CNT signals (alternating short and long atrioventicular sequences 40-150 ms) will be delivered at the same by right ventricular pacemaker leads temporarely connected to the Moderato device. |
| Effects of CNT pacing signals on blood pressure | aproximately onr hour | Blood pressure (mmHg) will be obtained in parallel with a Millar catheter from the femoral artery througout the study. |
Countries
Czechia
Contacts
PRINCIPAL_INVESTIGATORPetr Neuzil, MD, PhD
Na Homolce Hospital
Outcome results
None listed