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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

Summary

This trial tests a pacemaker device to see how safe and effective it is for patients with heart rhythm disorders.

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.Check my eligibility
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.See study design
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

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

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
~0 spots leftby Jul 2024