RecruitingNot ApplicableNCT06056817

Chronic Evaluation of Novel Pacemaker System


Sponsor

Calyan Technologies

Enrollment

10 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Calyan Pacemaker for people with bradycardia and ventricular pacing with rate response. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECalyan 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

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NCT06056817


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