Chronic Evaluation of Novel Pacemaker System

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Bradycardia

Clinical Trial Details

NCT number	NCT06056817
Study type	Interventional
Source	Calyan Technologies
Contact	Imad Libbus, PhD
Phone	763-657-1480
Email	imad@calyantech.com
Status	Not yet recruiting
Phase	N/A
Start date	October 1, 2023
Completion date	December 31, 2024

View Details

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