Chronic Evaluation of Novel Pacemaker System (NCT06056817) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Chronic Evaluation of Novel Pacemaker System
United States10 participantsStarted 2026-04-01
Plain-language summary
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
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
. Age 18 or above
. Willing and capable of providing informed consent
. Class I or IIa indication for implantation of a single-chamber ventricular pacemaker, according to ACC/AHA/HRS guidelines
. A life expectancy of at least one year, and is a suitable candidate based on overall health and well-being
Exclusion criteria
. Patients with complete AV block or other pacemaker-dependent conditions
. Patients in whom a substernal device implant should be avoided:
. Any prior sternotomy;
. Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space;
. Any marked sternal abnormality, such as pectus excavatum or pectus carinatum
. Prior abdominal surgery in the epigastric region
. Planned sternotomy
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
Incidence of procedure and device related serious adverse events (SAEs)
Timeframe: 3 months
2
Number of patients with successful chronic ventricular pacing