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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Calyan TechnologiesLead Sponsor

Imad Libbus, PhDStudy DirectorCalyan Technologies

7 Previous Clinical Trials

560 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers still being accepted into this clinical experiment?

"Per the information hosted on clinicaltrials.gov, this experiment is not in a state of recruitment at present. The initial posting was made October 1st 2023 and it was last amended September 21st 2023. Although no longer recruiting, there are 30 other trials actively seeking participants as we speak."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chronic Evaluation of Novel Pacemaker System

2023. "Chronic Evaluation of Novel Pacemaker System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06056817.