Health Trials

About this trial

The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients with complete AV block or other pacemaker-dependent conditions

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

Trial design

Treatments tested in this trial

  • Calyan Pacemaker

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

1
University of Minnesota55455, MinneapolisMinnesota, United States

Sponsors and collaborators

Calyan Technologies

Lead sponsor

Source ClinicalTrials.gov