Chronic Evaluation of Novel Pacemaker System

NAUnknownINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

March 31, 2025

Conditions
Ventricular Pacing With Rate ResponseBradycardia
Interventions
DEVICE

Calyan Pacemaker

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.

Trial Locations (1)

55455

University of Minnesota, Minneapolis

Sponsors
All Listed Sponsors
lead

Calyan Technologies

INDUSTRY