RecruitingNot ApplicableNCT05719454

Novel Setup Algorithm for Cardiac Neuromodulation Therapy

Clinical Feasibility of a Novel Setup Algorithm for BackBeat Medical's Cardiac Neuromodulation Therapy (CNT) Pacing Signals


Sponsor

BackBeat Medical Inc

Enrollment

30 participants

Start Date

Jun 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

After meeting all inclusion/exclusion criteria, subjects on standard pacing with the Moderato® or Moderato Plus Implantable Pulse Generator (IPG) will be subjected to two set-up sessions for the CNT algorithm: at week 4 and at week 6 post implant. At the end of these visits, subjects will undergo a 24 ambulatory blood pressure recording after which CNT will be automatically turned OFF and standard pacing will resume. The ambulatory data will provide the basis for a lasting CNT programming by week 8. Follow up visits will be scheduled after 3, 6, and 12 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new automatic programming method for a dual-chamber pacemaker that also provides a special heart nerve stimulation therapy (cardiac neuromodulation) to lower blood pressure in patients who have both a pacemaker indication and uncontrolled high blood pressure. **You may be eligible if...** - You are 18 or older and need a new or replacement dual-chamber pacemaker (or an upgrade from single to dual chamber) - You have high blood pressure (office systolic BP between 140-180 mmHg) on 1-3 blood pressure medications, which have been stable for at least 1 month - Your heart's pumping function is 50% or better **You may NOT be eligible if...** - Your high blood pressure is caused by a known secondary condition (e.g., thyroid disease, adrenal tumor) - You have permanent or frequent atrial fibrillation - You have significant heart failure symptoms (NYHA class II or above) - You have had a stroke or TIA in the past year, or a heart attack or heart procedure in the past 3-6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECNT testing

The effect of CNT on blood pressure will be obtained throughout the year long follow up period.


Locations(7)

Nemocnice Na Homolce (Na Homolce Hospital)

Prague, Czechia

Semmelweis University Heart and Vascular Center

Budapest, Hungary

Jagiellonian University Hospital

Krakow, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Samodzielny Pub. Szpital Kliniczny nr 2 PUM

Szczecin, Poland

Publiczny Centralny Szpital

Warsaw, Poland

Silesian Center for Heart Diseases

Zabrze, Poland

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NCT05719454


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