🏛️ Verified NIH Record • Updated 2026-03-16
Chronic Evaluation of Novel Pacemaker System (NCT06056817)
🟡 Not Yet Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Calyan Technologies
🩺 Plain-English Summary (8th-Grade Level)
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (27 items).
Location: University of Minnesota — Minneapolis, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- Prior or planned chest radiotherapy
- Hiatal hernia that distorts mediastinal anatomy
- Adhesions in the anterior mediastinal space
- Severe obesity so that subxiphoid/substernal tunneling cannot be safely performed
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Minnesota — Minneapolis, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.