Who is sponsoring NCT04421040?

NCT04421040 is sponsored by Mayo Clinic.

What drugs are being tested in NCT04421040?

Interventions in NCT04421040: Biotronik Biomonitor 3 implant of device, Biotronik Biomonitor 3 explant of device.

What condition does NCT04421040 study?

NCT04421040 studies TTR Cardiac Amyloidosis.

Is NCT04421040 still recruiting?

NCT04421040 is currently completed. Last updated 16 April 2024.

Are results published for NCT04421040?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-04-16 · How we verify

NCT04421040

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 16 April 2024

What this trial tests

NA trial testing Biotronik Biomonitor 3 implant of device in TTR Cardiac Amyloidosis in 24 participants. Completed in 22 March 2023.

Timeline

7 October 2020

Primary endpoint
22 March 2023

22 March 2023

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	24
Start date	7 October 2020
Primary completion	22 March 2023
Estimated completion	22 March 2023
Sites	1 location across United States

Drugs / interventions tested

Biotronik Biomonitor 3 implant of device
Biotronik Biomonitor 3 explant of device

Conditions studied

TTR Cardiac Amyloidosis — all drugs for TTR Cardiac Amyloidosis →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 85, any sex, with TTR Cardiac Amyloidosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sudden Death Primary · 6 months

Total number of patients to experience sudden death

Group	Value	95% CI
Biomonitor 3	0

Atrial Arrhythmias Primary · 6 months

Total number of participants to experience atrial arrhythmias

Group	Value	95% CI
Biomonitor 3	10

High Grade Atrioventricular (AV) Block Primary · 6 months

Total number of patients with high grade atrioventricular (AV) block.

Group	Value	95% CI
Biomonitor 3	2

Permanent Pacemaker Implantation Primary · 6 months

Total number of patients requiring permanent pacemaker implantation.

Group	Value	95% CI
Biomonitor 3	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for each participant for 6 months, from baseline until device ex-plantation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Biomonitor 3

Serious: 0/24 (0%)

Deaths: 2/24

Other adverse events (3 terms — click to expand)

Reaction	System	Biomonitor 3
Heart palpitations	Cardiac disorders	—
Fatigue	General disorders	—
Syncope	General disorders	—

Data from ClinicalTrials.gov NCT04421040 adverse events section.

Sponsor's own description

Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04421040 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 16 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04421040.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing