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.

Age range18 Years

SexALL

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

✓. 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

✕. 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
✕. Prior or planned chest radiotherapy

Incidence of procedure and device related serious adverse events (SAEs)

Timeframe: 3 months

Number of patients with successful chronic ventricular pacing

Timeframe: 3 months

NCT IDNCT06056817

SponsorCalyan Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09-30

Imad Libbus, PhD