Ventricular Pacing With Rate ResponseNCT06056817
Chronic Evaluation of Novel Pacemaker System
A study testing Calyan Pacemaker in people with Ventricular Pacing With Rate Response and Bradycardia, run by Calyan Technologies at 1 site in United States.
Trial summary
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Pacing With Rate Response, Bradycardia
- What is being tested?
- Calyan Pacemaker
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
- 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
- Patients who have previously undergone an open-heart surgical procedure.
- Patients with an active infection
- Patient on chronic oral anticoagulation which cannot be temporarily discontinued for surgery
- 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
- Patients who have tested positive for the COVID-19 in the past 3 months, or are currently showing symptoms consistent with COVID-19
- Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
- Subjects with a life expectancy of less than 12 months
- Patients who are currently enrolled or planning to participate in any concurrent clinical study with an investigational therapy
- Patients with decompensated heart failure expected to worsen with chronic RV pacing
- Patients with COPD with oxygen dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
Read the 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.
- Conditions
- Ventricular Pacing With Rate Response, Bradycardia
- Being tested
- Calyan Pacemaker
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Chronic implantation of the Calyan pacemaker device Receives: Device: Calyan Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Jul 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Pacing With Rate ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calyan Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Imad Libbus, PhD, Study director, Calyan Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056817
- Sponsor's protocol ID
- CT-05
- Status last verified
- Aug 2026
- First submitted
- 21 Sep 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Evaluation of Novel Pacemaker System
- ClinicalTrials.gov ID
- NCT06056817
- Acronym / sponsor ID
- CT-05
- Conditions
- Ventricular Pacing With Rate Response, Bradycardia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Calyan TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Calyan PacemakerChronic implantation of the Calyan pacemaker device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- Patients with complete AV block or other pacemaker-dependent conditions
- Patients in whom a substernal device implant should be avoided:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calyan PacemakerThe 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. | Device | Treatment |
Primary outcome
Incidence of procedure and device related serious adverse events (SAEs)
Time frame: 3 months
Rate of procedure and device related serious adverse events (SAEs) at 3 months post-implant.
Number of patients with successful chronic ventricular pacing
Time frame: 3 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Imad Libbus, PhD study director
Calyan Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calyan Pacemaker in people with Ventricular Pacing With Rate Response and Bradycardia, run by Calyan Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imad Libbus, PhD (763-657-1480, imad@calyantech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of procedure and device related serious adverse events (SAEs) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.