NCT06056817

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2.5 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

September 21, 2023

Last Update Submit

March 16, 2026

Conditions

Ventricular Pacing With Rate ResponseBradycardia

Outcome Measures

Primary Outcomes (2)

  • Incidence of procedure and device related serious adverse events (SAEs)

    Rate of procedure and device related serious adverse events (SAEs) at 3 months post-implant.

    3 months

  • Number of patients with successful chronic ventricular pacing

    Proportion of patients with successful chronic ventricular pacing, including successful pacemaker implantation and chronic capture of the ventricle, during the 3-month primary follow-up period.

    3 months

Study Arms (1)

Treatment

EXPERIMENTAL

Chronic implantation of the Calyan pacemaker device

Device: Calyan Pacemaker

Interventions

Calyan PacemakerDEVICE

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.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or above
  • Willing and capable of providing informed consent
  • Class I or IIa indication for implantation of a single-chamber ventricular pacemaker, according to ACC/AHA/HRS guidelines
  • A life expectancy of at least one year, and is a suitable candidate based on overall health and well-being

You may not qualify if:

  • Patients with complete AV block or other pacemaker-dependent conditions
  • Patients in whom a substernal device implant should be avoided:
  • Any prior sternotomy;
  • Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space;
  • Any marked sternal abnormality, such as pectus excavatum or pectus carinatum
  • Prior abdominal surgery in the epigastric region
  • Planned sternotomy
  • Prior or planned chest radiotherapy
  • Hiatal hernia that distorts mediastinal anatomy
  • Adhesions in the anterior mediastinal space
  • Severe obesity so that subxiphoid/substernal tunneling cannot be safely performed
  • Patients with severe RV dilation, gross hepatosplenomegaly, or severe obesity such that subxiphoidal/substernal tunneling cannot be safely performed
  • Patients with a class III indication for a permanent pacemaker
  • Patients with decompensated heart failure not due to bradycardia and expected to worsen with chronic RV pacing
  • Patients with an implanted cardiac pacemaker, cardioverter defibrillator, cardiac resynchronization device, or neurostimulator device, or planned implantation of a cardioverter defibrillator, cardiac resynchronization device, or neurostimulator device
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Imad Libbus, PhD

    Calyan Technologies

    STUDY DIRECTOR

Central Study Contacts

Imad Libbus, PhD

CONTACT

763-657-1480imad@calyantech.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

April 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)