ALPs Single ChambEr New Device Study (NCT07469579) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ALPs Single ChambEr New Device Study
15 participantsStarted 2026-06
Plain-language summary
Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.
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
. Male or female, ≥ 18 years of age at enrolment
. Subject who has a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS/EHRA guidelines:
. Paroxysmal or permanent high-grade AV block in the presence of Atrial Fibrillation (AF)
. Paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.
. Symptomatic bradycardia-tachycardia syndrome or Sinus Node Dysfunction (sinus bradycardia or sinus pauses), as an alternative to atrial or dual chamber pacing, when dual chamber transvenous pacing system is considered difficult, elevated risk, or not deemed necessary for effective therapy.
. Subject able and willing to undergo the study requirements and is expected to be geographically stable for the duration of the follow-up.
. Subject with a life expectancy of more than 24 months.
. Subject is able and willing to use the Home Monitor.
Exclusion criteria
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
1
Rate of device-related serious adverse events
Timeframe: 3 months
2
Rate of participants with pacing thresholds (PCT) ≤ 2V at 0.4 ms pulse width, and and an increase in PCT from implantation is less than 1.5V, and R-wave amplitudes ≥ 5.0 mV, or a value ≥ the value at implantation
. Subject who is entirely pacemaker dependent (escape rhythm \<30 bpm).
. Subject has an existing or prior pacemaker, ICD, or CRT device implant.
. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
. Subject had recent cardiovascular or peripheral vascular surgery within 30 days prior to enrollment
. Subject with current implantation of a neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
. Subject with a prior intervention of the tricuspid valve, implanted vena cava filter that cannot be crossed, or left ventricular assist device (LVAD).