Calyan Pacemaker for Heart Rhythm Disorders

Overseen By Imad Libbus, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Calyan Technologies

Must not be taking: Anticoagulants

Disqualifiers: Complete AV block, Severe obesity, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new pacemaker called the Calyan Pacemaker system. It aims to see if the device is safe and works well for patients who need help with their heart rhythms. The pacemaker helps the heart beat regularly by sending small electrical signals.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on chronic oral anticoagulation (blood thinners), it must be temporarily discontinued for surgery.

Is the Calyan Pacemaker generally safe for humans?

The safety data for pacemakers, including those from different manufacturers, show that malfunctions can occur, sometimes leading to serious consequences. For example, one study found that 16.4% of pacemakers had malfunctions, with significant clinical consequences in 5.3% of patients. Another report noted that certain pacemaker models had a production issue affecting 0.15% of devices, but no permanent harm was reported. It's important to discuss potential risks with your healthcare provider. ^{1 2 3 4 5}

How is the Calyan Pacemaker treatment different from other treatments for heart rhythm disorders?

The Calyan Pacemaker is unique because it may incorporate advanced features like frequency adaptation and early heart failure detection, which are not standard in all pacemakers. Additionally, it might offer physiological pacing that improves quality of life and reduces atrial fibrillation, setting it apart from traditional pacemakers. ^{6 7 8 9 10}

What data supports the effectiveness of the Calyan Pacemaker treatment for heart rhythm disorders?

Research on biventricular pacing, which is similar to the Calyan Pacemaker, shows it can improve symptoms and quality of life in patients with heart failure by helping the heart's chambers beat in sync. This suggests that the Calyan Pacemaker might also be effective for heart rhythm disorders. ^{11 12 13 14 15}

Who Is on the Research Team?

Imad Libbus, PhD

Principal Investigator

Calyan Technologies

Are You a Good Fit for This Trial?

Adults over 18 who need a single-chamber ventricular pacemaker and can consent to the study. They should expect to live at least one more year and be in good health overall. Not for those with active infections, recent or current COVID-19, pregnant/breastfeeding women, enrolled in other studies, severe heart failure/COPD, certain heart block conditions or device implants that conflict.

Inclusion Criteria

I am willing and able to give my consent for treatment.

You are expected to live for at least one more year and are in good overall health.

I am recommended to get a single-chamber ventricular pacemaker.

Exclusion Criteria

You are expected to live for less than 12 months.

You have a complete AV block or rely on a pacemaker for your heart condition.

I currently have an active infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

The Calyan pacemaker device is implanted in participants

1 week

Primary Follow-up

Chronic pacing is delivered and participants are monitored for safety and effectiveness

3 months

Extended Follow-up

Participants continue to be monitored for long-term safety and device stability

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Calyan Pacemaker

Trial Overview The trial is testing the Calyan Pacemaker system's safety and how well it works for people with slow heart rates needing ventricular pacing. It will assess if this new pacemaker is a feasible option compared to existing treatments.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Chronic implantation of the Calyan pacemaker device

Who Is Running the Clinical Trial?

Calyan Technologies

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

Permanent cardiac pacemakers are crucial for patients whose natural heart rate regulation fails, as they provide electrical stimulation to maintain a normal heart rate.

The article discusses the indications for needing a pacemaker, the technical aspects of the procedure, and the necessary care for patients undergoing this implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of permanent cardiac pacing. Jackson, A.[2011]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Biventricular pacing improves quality of life and exercise tolerance in patients with heart failure and intraventricular conduction delay. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Ventricular pacemaker upgrade: experience, complications and recommendations. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Reversal of Pacing-Induced Cardiomyopathy Following Cardiac Resynchronization Therapy. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A pilot experience with permanent biventricular pacing to treat advanced heart failure. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Cardiac devices in emergency department heart failure patients. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Managing pacemaker safety alerts: experience with three successive models of a single manufacturer. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Atrial pacing from the coronary vein. Ten-year experience in 50 patients with implanted pervenous pacemakers. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical classification of generator and electrode failures. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Approach to patients with Assurity® and Endurity® pacemakers : Recommendations from the nucleus of the Working Group Electrophysiology and Rhythmology of the German Cardiac Society]. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Cardiac implantable electronic device therapy for bradyarrhythmias and tachyarrhythmias. [2012]

12. Hungary pubmed.ncbi.nlm.nih.gov

[Latest results of treatment with pacemaker and implantable cardioverter defibrillators]. [2009]

13. United States pubmed.ncbi.nlm.nih.gov

The pacer-cardioverter-defibrillator: function and clinical experience. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Percutaneously injectable fetal pacemaker: electrodes, mechanical design and implantation. [2021]

15. England pubmed.ncbi.nlm.nih.gov

An overview of permanent cardiac pacing. [2011]