Chronic Evaluation of Novel Pacemaker System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCalyan Technologies
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 groupSponsors and collaborators
Source ClinicalTrials.gov