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NOT YET RECRUITING
NCT06056817
NA

Chronic Evaluation of Novel Pacemaker System

Sponsor: Calyan Technologies

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-04-01

Completion Date

2027-12-31

Last Updated

2026-03-18

Healthy Volunteers

No

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.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States