NCT06056817

Chronic Evaluation of Novel Pacemaker System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Calyan Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is an early feasibility study, designed to evaluate the initial clinical safety, device functionality and stability and potential effectiveness of the Calyan pacemaker. The Calyan device will be implanted, and if acute success criteria are met, chronic pacing will be delivered over a 3-month primary follow-up period, with subsequent extended follow-up of all patients. The data from this study will be used to justify the design of a larger prospective pivotal study that will assess the safety and effectiveness of the Calyan pacemaker device.

Conditions

• Ventricular Pacing With Rate Response
• Bradycardia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2023-09-28
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study