Preload and Autonomic Responses With Cardiac Neuromodulation Therapy (CNT) (CS-06)

Bradycardia Clinical Trial

— CS-06  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04463121
• Other study ID #: BBM MOD PV CS-06
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2022
• Source: BackBeat Medical Inc
• Contact: Yuval Mika, PhD
• Phone: +18569123155
• Email: ymika[@]orchestrabiomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Hypertension, Systolic

Intervention

Device:
• Moderato IPG's CNT pacing signals
Assesment of cardiac function and sympatheric activity will be obtained simultaneously
• 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.

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Praha

Sponsors (2)

Lead Sponsor	Collaborator
BackBeat Medical Inc	CD Leycom

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

de Roest GJ, Allaart CP, Kleijn SA, Delnoy PP, Wu L, Hendriks ML, Bronzwaer JG, van Rossum AC, de Cock CC. Prediction of long-term outcome of cardiac resynchronization therapy by acute pressure-volume loop measurements. Eur J Heart Fail. 2013 Mar;15(3):299-307. doi: 10.1093/eurjhf/hfs190. Epub 2012 Nov 25. — View Citation

Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, Petru J, Jongejan N, Aichinger J, Kamzola G, Aidietis A, Gellér L, Mraz T, Osztheimer I, Mika Y, Evans S, Burkhoff D, Kuck KH; BackBeat Study Investigators. Pacemaker-Mediated Programmable Hypertension Control Therapy. J Am Heart Assoc. 2017 Dec 23;6(12). pii: e006974. doi: 10.1161/JAHA.117.006974. — View Citation

Yang B, Wang Y, Zhang F, Ju W, Chen H, Mika Y, Aviv R, Evans SJ, Burkhoff D, Wang J, Chen M. Rationale and evidence for the development of a durable device-based cardiac neuromodulation therapy for hypertension. J Am Soc Hypertens. 2018 May;12(5):381-391. doi: 10.1016/j.jash.2018.03.004. Epub 2018 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of the Moderato CNT pacing signals on cardiac function	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.	approximately one hour
Primary	Effects of CNT pacing signals on blood pressure	Blood pressure (mmHg) will be obtained in parallel with a Millar catheter from the femoral artery througout the study.	aproximately onr hour