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Researchers are gathering information to see if using an FDA approved implantable device can help with monitoring of your heart arrhythmias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotronik Biomonitor 3 implant of device | Device | The Biotronik Biomonitor 3 device will be implanted by the research team physician. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sudden Death | Total number of patients to experience sudden death | 6 months |
| Atrial Arrhythmias | Total number of participants to experience atrial arrhythmias | 6 months |
| High Grade Atrioventricular (AV) Block | Total number of patients with high grade atrioventricular (AV) block. | 6 months |
| Permanent Pacemaker Implantation | Total number of patients requiring permanent pacemaker implantation. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Abou Ezzeddine, MD, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biomonitor 3 | 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. Biotronik Biomonitor 3 implant of device: The Biotronik Biomonitor 3 device will be implanted by the research team physician. Biotronik Biomonitor 3 explant of device: The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Biomonitor 3 | 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. Biotronik Biomonitor 3 implant of device: The Biotronik Biomonitor 3 device will be implanted by the research team physician. Biotronik Biomonitor 3 explant of device: The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sudden Death | Total number of patients to experience sudden death | Posted | Count of Participants | Participants | 6 months |
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Adverse events were collected for each participant for 6 months, from baseline until device ex-plantation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biomonitor 3 | 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. Biotronik Biomonitor 3 implant of device: The Biotronik Biomonitor 3 device will be implanted by the research team physician. Biotronik Biomonitor 3 explant of device: The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart palpitations | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace Lin | Mayo Clinic | 507-255-1267 | lin.grace@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2023 | Feb 19, 2024 | Prot_SAP_000.pdf |
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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.
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| Biotronik Biomonitor 3 explant of device | Device | The Biotronik Biomonitor 3 device will be removed from the patient by the research team physician. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Atrial Arrhythmias | Total number of participants to experience atrial arrhythmias | Posted | Count of Participants | Participants | 6 months |
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| Primary | High Grade Atrioventricular (AV) Block | Total number of patients with high grade atrioventricular (AV) block. | Posted | Count of Participants | Participants | 6 months |
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| Primary | Permanent Pacemaker Implantation | Total number of patients requiring permanent pacemaker implantation. | Posted | Count of Participants | Participants | 6 months |
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| 2 |
| 24 |
| 0 |
| 24 |
| 8 |
| 24 |
| Fatigue | General disorders | Systematic Assessment |
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| Syncope | General disorders | Systematic Assessment |
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