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This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Time to diagnosis | Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded. | The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion procedure and success | Information on the insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and insertion tool); Success rate of insertions. | Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensing and noise | Quality of sensing Amplitude (Millivolt) and electrical noise (%) detected by the BIOMONITOR. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Inspection results of the insertion site |
Inclusion Criteria:
Exclusion Criteria:
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The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabrina Hoche, Dr. | Contact | +49 30 68905 | 1337 | biomonitor-registry@biotronik.com |
| Dörte Vossmeyer, Dr. | Contact | +49 30 68905 | 1306 | biomonitor-registry@biotronik.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integral Health | Recruiting | Adelaide | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37025684 | Derived | Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023. |
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Rating of wound healing and cosmetic outcome by the physician/patient (5-level scale).
| Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Patient contentment regarding BIOMONITOR wearability | Patients opinion about the wearing comfort (5-level-scale). | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Device migration | Assessement whether the BIOMONITOR migrates under the skin. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Diagnosis and clinical actions after arrhythmia detection | Documentation whether the BIOMONITOR helps to detect arrhythmias. Documentation of therapies used to treat these arrhythmias and whether the BIOMONITOR helps to monitor therapy success. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Explantation / deactivation / exchange information of the BIOMONITOR | Collect information about explantation, deactivation and exchanges of the BIOMONITOR, such as number, reason, and data on procedure. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Adverse Events | Collect and analyze adverse events. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Device Deficiencies | Collect and analyze device deficiencies. Calculate rate (frequency) of device deficiencies. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Documentation of imaging techniques, if applied. | Documentation if patients underwent any MRI examinations or mammography. Documentation of exact kind of examination and occurrences with regard to the BIOMONITOR. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). |
| Royal Adelaide Hospital | Completed | Adelaide | Australia |
| Nemocnice Ceske Budejovice, a.s. | Recruiting | České Budějovice | 37001 | Czechia |
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| Hôpital Saint-André | Completed | Bordeaux | France |
| Le Centre Hospitalier Universitaire de Brest (CHRU Brest) | Recruiting | Brest | France |
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| Le Centre Hospitalier Universitaire de Caen (CHRU Caen) | Recruiting | Caen | France |
|
| Le Centre Hospitalier Universitaire de Tours (CHRU Tours) | Active, not recruiting | Chambray-lès-Tours | France |
| Hôpital Gabriel Montpied | Recruiting | Clermont-Ferrand | France |
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| Hôpital Haut Lévêque (CHU) | Recruiting | Pessac | France |
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| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | France |
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| St. Marienkrankhaus Klinikum Westmünsterland GmbH | Recruiting | Ahaus | Germany |
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| Kerckhoff-Klinik GmbH | Recruiting | Bad Nauheim | Germany |
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| Rhön-Klinikum | Active, not recruiting | Bad Neustadt an der Saale | Germany |
| Universitätsklinik an der Technischen Universität Dresden | Completed | Dresden | Germany |
| Helios Klinikum Erfurt | Recruiting | Erfurt | Germany |
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| Klinikum Herford | Recruiting | Herford | Germany |
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| Helios Health Institute GmbH | Recruiting | Leipzig | Germany |
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| Deutsches Herzzentrum der Charité | Recruiting | Mitte | Germany |
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| Klinikum rechts der Isar der Technischen Universität München | Active, not recruiting | München | Germany |
| Deutsches Herzzentrum der Charité | Recruiting | Steglitz | Germany |
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| Ospedale Civile Ferrari | Recruiting | Castrovillari | Italy |
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| Ospedale Maria Vittoria | Recruiting | Torino | Italy |
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| Pauls Stradins Clinical University Hospital | Recruiting | Riga | 1002 | Latvia |
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| Unidade Local de Saúde do Alto Ave, E. P. E. | Recruiting | Guimarães | Portugal |
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| Unidade Local de Saúde de Santa Maria, E. P. E. | Recruiting | Lisbon | Portugal |
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| Centro Médico Teknon | Recruiting | Erandio | Spain |
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| Hospital de Fuenlabrada | Active, not recruiting | Fuenlabrada | Spain |
| Hospital Álvaro Cunqueiro | Recruiting | Vigo | Spain |
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| Hospital Universitario de Araba | Recruiting | Vitoria-Gasteiz | Spain |
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| GZO Spital Wetzikon | Completed | Wetzikon | Switzerland |
| Universitätsspital Zürich (USZ) | Recruiting | Zurich | Switzerland |
|
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001281 | Atrial Fibrillation |
| D013575 | Syncope |
| D001919 | Bradycardia |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
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