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Procedure

Calyan Pacemaker for Heart Rhythm Disorders

N/A
Waitlist Available
Research Sponsored by Calyan Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and capable of providing informed consent
Age 18 or above
Must not have
Patients with an active infection
Patients who have tested positive for the COVID-19 in the past 3 months, or are currently showing symptoms consistent with COVID-19
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, typical risks may include infection at the implant site, bleeding or bruising, allergic reactions to materials used in the pacemaker or during surgery complications related to device implantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to give my consent for treatment.
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I am 18 years old or older.
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I am recommended to get a single-chamber ventricular pacemaker.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an active infection.
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I have tested positive for COVID-19 or shown symptoms in the last 3 months.
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I am on long-term blood thinners that can't be stopped for surgery.
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I am not pregnant or breastfeeding.
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My heart condition is expected to worsen with certain heart pacing treatments.
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I have COPD and need oxygen.
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I cannot have heart pacing due to conditions like severe pericarditis or other similar heart issues.
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I have had open-heart surgery before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of procedure and device related serious adverse events (SAEs)
Number of patients with successful chronic ventricular pacing

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Chronic implantation of the Calyan pacemaker device

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for slow heart rate (bradycardia) include the use of pacemakers, which are devices that deliver electrical stimulation to regulate heart rhythm. Pacemakers work by sending electrical impulses to the heart to ensure it beats at a normal rate. This is crucial for patients with bradycardia because a slow heart rate can lead to insufficient blood flow to the body's organs, causing symptoms like fatigue, dizziness, and fainting. By maintaining an adequate heart rate, pacemakers help improve blood circulation and overall quality of life for these patients.

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Who is running the clinical trial?

Calyan TechnologiesLead Sponsor
Imad Libbus, PhDStudy DirectorCalyan Technologies
7 Previous Clinical Trials
560 Total Patients Enrolled
~7 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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