Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06) (CS-06)
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|ClinicalTrials.gov Identifier: NCT04463121|
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : August 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bradycardia Hypertension, Systolic||Device: Moderato IPG's CNT pacing signals Device: CD Leycom Pressure/Volume Combination Catheters||Not Applicable|
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 either from the femoral artery sheath through which the conductance catheter is introduced, or from a radial arterial line.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Pressure-Volume (PV) Measurements for Evaluating the Changes in the Ventricular Preload and Autonomic Nervous System Using BackBeat Medical Cardiac Neuromodulation Therapy (CNT) Signals in an Acute Study|
|Actual Study Start Date :||August 7, 2020|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
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.
Device: Moderato IPG's CNT pacing signals
Assesment of cardiac function and sympatheric activity will be obtained simultaneously
Device: CD 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.
- Effects of the Moderato CNT pacing signals on cardiac function [ Time Frame: 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 [ Time Frame: aproximately onr hour ]Blood pressure (mmHg) will be obtained in parallel with a Millar catheter from the femoral artery througout the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04463121
|Contact: Yuval Mika, PhDfirstname.lastname@example.org|
|Contact: Norbert Rosenthalemail@example.com|
|Na Homolce Hospital||Recruiting|
|Praha, Czechia, 15030|
|Contact: Petr Neuzil, MD, PhD +420 257272211 Peter.Neuzil@homolka.cz|
|Contact: Libor Dujka, MD +420731486352 firstname.lastname@example.org|
|Principal Investigator: Petr Neuzil, MD, PhD|
|Sub-Investigator: Filip Malek, MD, PhD|
|Sub-Investigator: Jan Petru, MD|
|Sub-Investigator: Milan Chovanec, MD|
|Sub-Investigator: Libor Dujka, MD|
|Principal Investigator:||Petr Neuzil, MD, PhD||Na Homolce Hospital|