Chronic Evaluation of a New Pacemaker System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early feasibility study will implant the Calyan pacemaker to assess its initial safety, device function, and stability over a 3‑month primary follow-up, with extended monitoring afterward. If acute success is achieved, chronic pacing will be delivered during the defined follow-up, and data will support planning for a larger pivotal trial. The study aims to determine whether the Calyan system can provide effective pacing in eligible adults and identify any early safety concerns. Enrollment requires informed consent and a single‑chamber ventricular pacemaker indication per ACC/AHA/HRS guidelines, with several exclusions to avoid high‑risk anatomical or prior surgical conditions. The trial is sponsored by Calyan Technologies and conducted at the University of Minnesota.

Why it matters

Who can join: the full rules

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
   9. Severe obesity so that subxiphoid/substernal tunneling cannot be safely performed
3. Patients with severe RV dilation, gross hepatosplenomegaly, or severe obesity such that subxiphoidal/substernal tunneling cannot be safely performed
4. Patients with a class III indication for a permanent pacemaker
5. Patients with decompensated heart failure not due to bradycardia and expected to worsen with chronic RV pacing
6. 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
7. Patients with a current or planned implantation of a substernal device, or any implanted device that would interfere with the implantation or operation of a substernal device
8. Patients who have previously undergone an open-heart surgical procedure.
9. Patients with an active infection
10. Patient on chronic oral anticoagulation which cannot be temporarily discontinued for surgery
11. Patients with a condition in which pericardial pacing would be difficult or impossible, such as acute pericarditis, chronic pericardial effusion or pericardial thickening or calcification, cardiac tamponade, or chronic restrictive pericarditis
12. Patients who have tested positive for the COVID-19 in the past 3 months, or are currently showing symptoms consistent with COVID-19
13. Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
14. Subjects with a life expectancy of less than 12 months
15. Patients who are currently enrolled or planning to participate in any concurrent clinical study with an investigational therapy
16. Patients with decompensated heart failure expected to worsen with chronic RV pacing
17. Patients with COPD with oxygen dependence

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Imad Libbus, PhD
• Email: imad@calyantech.com
• Phone: 763-657-1480

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.