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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new pacemaker, the Calyan Pacemaker, to determine its safety and effectiveness for individuals with certain heart rhythm issues. It is designed for those requiring a single-chamber ventricular pacemaker, assisting the heart's lower chamber in maintaining a regular beat. Individuals who have not undergone open-heart surgery and do not rely on a pacemaker for every heartbeat may be suitable candidates. The trial aims to assess whether this pacemaker can be a reliable option for those with specific heart problems. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

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.

What prior data suggests that the Calyan Pacemaker is safe for heart rhythm disorders?

Research has shown that the safety of pacemakers, including the Calyan Pacemaker, remains under careful study. Pacemakers can occasionally encounter problems that may lead to serious issues. Current studies are examining the device's safety and effectiveness, but detailed results about specific side effects for the Calyan Pacemaker are not yet available. More research is needed to fully understand its long-term safety. Prospective participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Calyan Pacemaker is unique because it offers a new approach to managing heart rhythm disorders through chronic implantation, setting it apart from traditional pacemakers. Most pacemakers focus on maintaining a steady heartbeat by delivering electrical impulses. However, the Calyan Pacemaker introduces an innovative design that potentially enhances the precision and efficiency of electrical pulse delivery, offering improved adaptability to the patient's needs. Researchers are excited about this device because it could lead to better patient outcomes, including fewer complications and longer battery life, which are significant advancements over existing options.

What evidence suggests that the Calyan Pacemaker is effective for heart rhythm disorders?

Studies suggest that the Calyan Pacemaker, which participants in this trial will receive, may effectively treat heart rhythm disorders. For example, research on a similar pacemaker showed a high success rate of 98% for placing the device without issues. Another study found a 97% success rate with a method called left bundle branch pacing, related to pacemaker use. These findings indicate that pacemakers like the Calyan can be successfully used and may effectively manage heart rhythm problems. However, malfunctions can occur. Specifically, one study found that 16.4% of pacemakers had issues, with significant problems in 5.3% of cases. ^{1 2 4 6 7}

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

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

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

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. withpower.com withpower.com/trial/phase-bradycardia-9-2023-00142

Calyan Pacemaker for Heart Rhythm Disorders 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06056817

Chronic Evaluation of Novel Pacemaker System Study Overview. The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06056817/chronic-evaluation-of-novel-pacemaker-system

Chronic Evaluation of Novel Pacemaker System The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.120.008874

Pros and Cons of Left Bundle Branch Pacing | Circulation Results: A total of 57 of 59 patients underwent successful LBBP (success rate 97%). The average follow-up duration was 6.2±5 months.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12195446/

Systematic Review and Meta-Analysis of Acute Mortality ... A database analysis from multiple centres in Europe reports a 98% success rate in leadless pacemaker placements, which aligns with other study ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)01363-8/pdf

PO-03-035 FIRST-IN-MAN IMPLANTATION AND ... Further chronic studies are required to evaluate the safety and performance of this novel pacing platform. PO-03-036. MAJOR ADVERSE CLINICAL EVENTS AND DEVICE.

7. researchgate.net researchgate.net/publication/378656620_Safety_and_performance_of_a_novel_subxiphoidal_pacemaker_system

Safety and performance of a novel subxiphoidal ... Adverse events will be recorded throughout the study period. Conclusion This study is designed to assess the feasibility, safety, and chronic performance of a ...