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Implantable Event Monitors for Cardiac Amyloidosis

N/A

Waitlist Available

Led By Grace Lin, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is to see if an implantable device can help monitor and treat heart arrhythmias.

Eligible Conditions

Transthyretin Cardiac Amyloidosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Atrial arrhythmias

High grade AV block

Sinus node dysfunction

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Biomonitor 3Experimental Treatment2 Interventions

Placement of Biotronic 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronic 3 device removed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biotronic 3 implant of device

2020

N/A

~30

Biotonic 3 explant of device

2020

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,760 Total Patients Enrolled

2 Trials studying Cardiac Amyloidosis

300 Patients Enrolled for Cardiac Amyloidosis

Grace Lin, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus, Mayo Clinic Rochester

Loyola University Of Chicago Stritch School Of Medicine (Medical School)

Mayo Grad School Med/Mayo Fndn (Residency)

1 Previous Clinical Trials

1,000 Total Patients Enrolled

Omar Abou Ezzeddine, MD, MSPrincipal InvestigatorMayo Clinic

Media Library

Biotonic 3 explant of device Clinical Trial Eligibility Overview. Trial Name: NCT04421040 — N/A

Cardiac Amyloidosis Research Study Groups: Biomonitor 3

Cardiac Amyloidosis Clinical Trial 2023: Biotonic 3 explant of device Highlights & Side Effects. Trial Name: NCT04421040 — N/A

Biotonic 3 explant of device 2023 Treatment Timeline for Medical Study. Trial Name: NCT04421040 — N/A

Frequently Asked Questions

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

Are more individuals being sought for participation in this experiment?

"Affirmative. The information posted on clinicaltrials.gov confirms that this trial, which originally began recruiting patients in October 2020, is still actively searching for volunteers. A total of 50 individuals must be enrolled from 2 separate sites."

Answered by AI

Is my participation in this clinical experiment possible?

"This clinical research initiative is seeking 50 individuals diagnosed with amyloidosis. The required criteria include classification into stages I, II and early/late stage III of the disease, age between 18-85 years old, both genders as well as all races/ethnicities, and ability to have a Biomonitor 3 device implanted."

Answered by AI

Is enrollment for this research restricted to people under 30?

"Individuals aged between 18 and 85 are eligible for the trial."

Answered by AI

What is the current sample size of this research project?

"Affirmative. According to information posted on clinicaltrials.gov, this medical experiment is actively enrolling patients as of August 8th 2022. Initially announced in October 2020, the trial requires 50 participants from 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors

Omar Abou Ezzeddine 2020. "Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04421040.