PV Loops With CNT in Multiple Pacing Sites (NCT05345925) | Clinical Trial Compass
CompletedNot Applicable
PV Loops With CNT in Multiple Pacing Sites
Poland5 participantsStarted 2023-05-19
Plain-language summary
In a multicenter non-randomized acute setting, eligible subjects requiring implant or replacement of an IPG (pacemaker, ICD, CRT-P, CRT-D) will be instrumented to study the effect of CNT from different locations in the RV. CNT effects on BP will be evaluated with a PV conductance catheter in the LV, and with optional BP catheters in the aorta and/or RV. CNT will be delivered by externally by the BackBeat Moderato System IPG.
Abbreviations: CNT, Cardiac Neuromodulation Therapy; IPG, Implanted Pulse Generator; ICD, Implanted Cardiac Defribillator; CRT-P or D, Cardiac Resynchronisation Therapy-Pacemaker or Defibrillator; RV, Right Ventricle; LV, Left Ventricle; BP, Blood Pressure
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 is indicated for an implant or a replacement with a planned upgrade of a device capable of pacing (pacemaker, ICD, CRT-P, CRT-D).
* Subject is willing and able to comply with the study procedures.
Exclusion Criteria:
* Subject is dependent on 100% ventricular pacing.
* Subject has symptoms of heart failure, NYHA Class III or greater
* Subject has an ejection fraction of 25% or less
* Subject's systolic blood pressure is less than 100 mmHg on the day of implant
* Subject has decompensated heart failure
* Subject has significant (\>2+) valvular regurgitation or any valvular 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) at any prior time that has resulted in residual neurologic deficit.
* Subject has a history of autonomic dysfunction
* Patient cannot receive heparin for any reason (such as a history of Heparin induced thrombocytopenia (HIT))
* Women who are pregnant or breast-feeding
* Subject cannot or is unwilling to provide informed consent.
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.
1This trial tested pacing in multiple different sites in the heart to see how it affects blood pressure — could you explain how the location of a pacemaker lead might actually change how well my heart pumps, and whether that matters for my specific type of A-V block or bradycardia?
2The trial measured changes in systolic blood pressure as its main outcome — what does blood pressure tell us about how effectively a pacemaker is supporting heart function, and is that something relevant to how my treatment would be evaluated?
3Since this study is already completed, has any data or findings from it been published, and if so, could you help me understand whether those results might influence the pacing approach you'd recommend for me?
4This trial was categorized as 'Not Applicable' for phase, which often means it's a device or procedure study rather than a drug trial — how does that affect what we know about the safety and benefit of the pacing sites they were testing compared to more established approaches?
5Are there standard pacing strategies already proven for my condition that I should consider first, and in what situation might the kind of multi-site pacing explored in this trial be worth discussing as an option for me?
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.