NCT04463121

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

August 7, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

2.6 years

First QC Date

June 30, 2020

Last Update Submit

September 15, 2022

Conditions

BradycardiaHypertension, Systolic

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Acute CNT pacing signals testing

EXPERIMENTAL

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 signalsDevice: CD Leycom Pressure/Volume Combination Catheters

Interventions

Moderato IPG's CNT pacing signalsDEVICE

Assesment of cardiac function and sympatheric activity will be obtained simultaneously

Acute CNT pacing signals testing
CD Leycom Pressure/Volume Combination CathetersDEVICE

Simultaneous recording of the Pressure, Volume measurements and ECG signals will be done for constant monitoring of intra-ventricular pressure and volume.

Acute CNT pacing signals testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Na Homolce Hospital

Prague, 15030, Czechia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 29628351BACKGROUND

  • 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, Geller 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):e006974. doi: 10.1161/JAHA.117.006974.

    PMID: 29275370BACKGROUND

  • 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.

    PMID: 23183349BACKGROUND

MeSH Terms

Conditions

BradycardiaIsolated Systolic Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEssential HypertensionHypertensionVascular Diseases

Study Officials

  • Petr Neuzil, MD, PhD

    Na Homolce Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Mika, PhD

CONTACT

+18569123155ymika@orchestrabiomed.com

Norbert Rosenthal

CONTACT

+491792482543nrosenthal@orchestrabiomed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 9, 2020

Study Start

August 7, 2020

Primary Completion

March 31, 2023

Study Completion

July 31, 2023

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations

CZ(1)