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Chronic Evaluation of Novel Pacemaker System

NCT06056817•Calyan Technologies

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Patients with complete AV block or other pacemaker-dependent conditions
•2. Patients in whom a substernal device implant should be avoided:
•1. Any prior sternotomy;
•2. Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space;
•3. Any marked sternal abnormality, such as pectus excavatum or pectus carinatum
•4. Prior abdominal surgery in the epigastric region
•5. Planned sternotomy
•6. Prior or planned chest radiotherapy
•7. Hiatal hernia that distorts mediastinal anatomy
•8. Adhesions in the anterior mediastinal space
+16 more criteria

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

April 1, 2026

Primary Completion Date

September 30, 2027

Completion Date

December 31, 2027

Last Updated

March 18, 2026

Enrollment

ESTIMATED participants

Conditions

Ventricular Pacing With Rate ResponseBradycardia

Interventions

Calyan Pacemaker

DEVICE

Contacts

Imad Libbus, PhD

CONTACT

763-657-1480 imad@calyantech.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Chronic Evaluation of Novel Pacemaker System

Inclusion Criteria

Exclusion Criteria

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