CompletedNot Applicable

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

Czechia22 participantsStarted 2020-08-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effects of the Moderato CNT pacing signals on cardiac function

Timeframe: approximately one hour

Effects of CNT pacing signals on blood pressure

Timeframe: aproximately onr hour

Trial details

NCT IDNCT04463121

SponsorBackBeat Medical Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-16

View on ClinicalTrials.gov More Bradycardia trials