NCT06056817 Chronic Evaluation of Novel Pacemaker System
| NCT ID | NCT06056817 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Calyan Technologies |
| Condition | Ventricular Pacing With Rate Response |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-07-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
Eligibility Criteria
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
Contact & Investigator
Imad Libbus, PhD
STUDY DIRECTOR
Calyan Technologies
Frequently Asked Questions
Who can join the NCT06056817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Pacing With Rate Response. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06056817 currently recruiting?
Yes, NCT06056817 is actively recruiting participants. Contact the research team at imad@calyantech.com for enrollment information.
Where is the NCT06056817 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06056817 clinical trial?
NCT06056817 is sponsored by Calyan Technologies. The principal investigator is Imad Libbus, PhD at Calyan Technologies. The trial plans to enroll 10 participants.