Chronic Evaluation of Novel Pacemaker System

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Calyan Technologies
Study ID
NCT06056817
Status
Not Yet Recruiting

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Conditions

  • Bradycardia
  • Ventricular Pacing With Rate Response

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Calyan Pacemaker — DEVICE
    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.

Study Details

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

Key Dates

Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Treatment
    Chronic implantation of the Calyan pacemaker device

Primary Outcome Measure

Incidence of procedure and device related serious adverse events (SAEs) [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455-

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By research site
University of Minnesota· Minneapolis, MN

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