TTR Cardiac AmyloidosisNCT04421040

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

A study testing Biotronik Biomonitor 3 implant of device and Biotronik Biomonitor 3 explant of device in people with TTR Cardiac Amyloidosis, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 85 years
Conditions the study is for: TTR Cardiac Amyloidosis
What is being tested?: Biotronik Biomonitor 3 implant of device and Biotronik Biomonitor 3 explant of device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2020to 22 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cardiac biopsy or technetium pyrophosphate scintigraphy confirmed patients
Stage I, II, and early and late stage III in numbers as described , irrespective of EF or NYHA functional class
Patients aged 18 -85, both genders and of all races and ethnicities.
Patients must be competent to give informed consent.
Patients must be able to have the Biomonitor 3 implanted.
Amyloid stage I-III patients with existing implantable cardiac devices such as pacemakers or defibrillators

Who cannot join

Significant coronary artery disease > 75% luminal stenosis in at least 1 epicardial vessel (by cardiac catheterization or coronary computed tomography), or history of myocardial infarction or coronary revascularization.
Congenital heart disease.
Pregnant patients
Patients whose heart failure is felt to be secondary to primary valvular disease (>moderate/severe mitral regurgitation), uncorrected thyroid disease, obstructive or hypertrophic cardiomyopathy, pericardial disease or a systemic illness.
Absolute contraindications to cardiac MRI (such as renal failure with GFR<30%).
Unwilling or unable to provide informed consent.

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Patients with other life threatening diseases that would likely decrease their life expectancy over the next four years.
Patients who are post cardiac transplant.
Difficulty to attend the follow-up schedule due to a history of medical noncompliance, difficulty, or unwillingness to return to the study center for follow up.
Evidence of ongoing bacteremia or sepsis preventing implantation of a device
Unwilling or able to have the Biomonitor 3 interrogated

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

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

Conditions: TTR Cardiac Amyloidosis
Being tested: Biotronik Biomonitor 3 implant of device, Biotronik Biomonitor 3 explant of device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biotronik Biomonitor 3 implant of deviceDevice
The Biotronik Biomonitor 3 device will be implanted by the research team physician.
Biotronik Biomonitor 3 explant of deviceDevice
The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician.

Study groups in NCT04421040
Study group	Role	What they receive
Biomonitor 3	Experimental	Placement of Biotronik Biomonitor 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronik Biomonitor 3 device removed. Receives: Device: Biotronik Biomonitor 3 implant of device; Device: Biotronik Biomonitor 3 explant of device

What is being measured

The primary outcome is the main question the study is designed to answer.

Sudden Death
Total number of patients to experience sudden death
Measured: 6 months
Atrial Arrhythmias
Total number of participants to experience atrial arrhythmias
Measured: 6 months
High Grade Atrioventricular (AV) Block
Total number of patients with high grade atrioventricular (AV) block.
Measured: 6 months
Permanent Pacemaker Implantation
Total number of patients requiring permanent pacemaker implantation.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202022 Mar 2023

First posted9 Jun 2020
Study start7 Oct 2020
Primary completion22 Mar 2023
Study completion22 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TTR Cardiac AmyloidosisStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: Patients with TTR-wt cardiac amyloidosis will be monitored with an implantable loop recorder to determine frequency of atrial and ventricular arrhythmias. After 6 months the device will be explanted unless required for further clinical monitoring.
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04421040
Sponsor's protocol ID: 17-006298
Status last verified: Mar 2024
First submitted: 5 Jun 2020
Last updated: 16 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Active, not recruitingPhase 3
A Phase 3 Study of NTLA-2001 in ATTRv-PN
Neuromuscular Disease, Neuromuscular Diseases (NMD)
RecruitingPhase 3
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

All TTR Cardiac Amyloidosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Monitoring of Patients With Cardiac Amyloidosis With Implantable Event Monitors
ClinicalTrials.gov ID: NCT04421040
Acronym / sponsor ID: 17-006298
Conditions: TTR Cardiac Amyloidosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 7 Oct 2020 (actual)
Primary completion: 22 Mar 2023 (actual)
Study completion: 22 Mar 2023 (actual)
First posted: 9 Jun 2020 (actual)
Results: Posted 16 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Patients with TTR-wt cardiac amyloidosis will be monitored with an implantable loop recorder to determine frequency of atrial and ventricular arrhythmias. After 6 months the device will be explanted unless required for further clinical monitoring.

Arm	Type	Receives
Biomonitor 3	Experimental	Device: Biotronik Biomonitor 3 implant of device, Device: Biotronik Biomonitor 3 explant of devicePlacement of Biotronik Biomonitor 3 Device for a 6 month period. After the 6 month monitoring period, the patient will have the Biotronik Biomonitor 3 device removed.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Cardiac biopsy or technetium pyrophosphate scintigraphy confirmed patients
Stage I, II, and early and late stage III in numbers as described , irrespective of EF or NYHA functional class
Patients aged 18 -85, both genders and of all races and ethnicities.
Patients must be competent to give informed consent.
Patients must be able to have the Biomonitor 3 implanted.

Key exclusion criteria (11 listed)

Significant coronary artery disease > 75% luminal stenosis in at least 1 epicardial vessel (by cardiac catheterization or coronary computed tomography), or history of myocardial infarction or coronary revascularization.
Congenital heart disease.
Pregnant patients
Patients whose heart failure is felt to be secondary to primary valvular disease (>moderate/severe mitral regurgitation), uncorrected thyroid disease, obstructive or hypertrophic cardiomyopathy, pericardial disease or a systemic illness.
Absolute contraindications to cardiac MRI (such as renal failure with GFR<30%).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biotronik Biomonitor 3 implant of deviceThe Biotronik Biomonitor 3 device will be implanted by the research team physician.	Device	Biomonitor 3
Biotronik Biomonitor 3 explant of deviceThe Biotronik Biomonitor 3 device will be removed from the patient by the research team physician.	Device	Biomonitor 3

Primary outcome

Sudden Death
Time frame: 6 months
Total number of patients to experience sudden death
Atrial Arrhythmias
Time frame: 6 months
Total number of participants to experience atrial arrhythmias
High Grade Atrioventricular (AV) Block
Time frame: 6 months
Total number of patients with high grade atrioventricular (AV) block.
Permanent Pacemaker Implantation
Time frame: 6 months
Total number of patients requiring permanent pacemaker implantation.

Results and safety

Results posted to the registry on 16 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biomonitor 3	24	24

Primary outcome: Sudden Death

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Biomonitor 3 n = 24
Value	0

Primary outcome: Atrial Arrhythmias

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Biomonitor 3 n = 24
Value	10

Primary outcome: High Grade Atrioventricular (AV) Block

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Biomonitor 3 n = 24
Value	2

Primary outcome: Permanent Pacemaker Implantation

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Biomonitor 3 n = 24
Value	3

Adverse events

Time frame: Adverse events were collected for each participant for 6 months, from baseline until device ex-plantation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biomonitor 3	0 of 24 (0%)	8 of 24 (33.3%)	2 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for TTR Cardiac Amyloidosis

Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Active, not recruitingPhase 3
A Phase 3 Study of NTLA-2001 in ATTRv-PN
Neuromuscular Disease, Neuromuscular Diseases (NMD)
RecruitingPhase 3
MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Omar Abou Ezzeddine, MD, MS principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biotronik Biomonitor 3 implant of device and Biotronik Biomonitor 3 explant of device in people with TTR Cardiac Amyloidosis, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sudden Death (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04421040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.