Chronic Evaluation of Novel Pacemaker System

ConditionsVentricular Pacing With Rate Response Bradycardia

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Calyan Pacemaker
Device
The Calyan pacemaker is a device designed for implantation in the chest below the xiphoid process, and includes a FlexArm containing stimulation and sensing electrodes. The Calyan pacemaker is implanted using a set of delivery tools and clipped onto the xiphoid process; the FlexArm electrodes are oriented to make contact with the pericardial surface of the heart. Pacing parameters are adjusted wirelessly with a tablet-based programmer that communicates with the Calyan pacemaker via secure Bluetooth.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Rate of procedure and device related serious adverse events (SAEs) at 3 months post-implant.

Time frame

3 months

Number of patients with successful chronic ventricular pacing

Proportion of patients with successful chronic ventricular pacing, including successful pacemaker implantation and chronic capture of the ventricle, during the 3-month primary follow-up period.

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Calyan Technologies

Lead sponsor

Source ClinicalTrials.gov

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