Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs) (BIOSTREAM-ICM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075084
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief Summary:
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.

Condition or disease
Tachycardia Atrial Fibrillation Syncope Bradycardia Cryptogenic Stroke

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Actual Study Start Date : October 28, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Time to diagnosis [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    Device is intended to detect rare arrhythmias. Time to detect this relevant arrhytmia will be recorded.


Secondary Outcome Measures :
  1. Insertion procedure and success [ Time Frame: It is considered that all patients are enrolled and subsequently inserted with the investigational device within 2 years after study start, i.e. until October 2021. Exchanges will be also considered for analysis ]
    Information on the Insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and inserton tool); Success rate of insertions.


Other Outcome Measures:
  1. Sensing and noise [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    Quality of sensing Amplitude (Millivolt) and electrical noise (%) detected by the BIOMONITOR.

  2. Inspection results of the insertion site [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    Rating of wound healing and cosmetic outcome by the physician/patient (5-level scale).

  3. Patient contentment regarding BIOMONITOR wearability [ Time Frame: Data will be collected throughout the entire registry, i.e. until Febraury 2023 (Last patient out). ]
    Patients opinion about the wearing comfort (5-level-scale).

  4. Device migration [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    Assessement whether the BIOMONITOR migrates under the skin.

  5. Diagnosis and clinical actions after arrhythmia detection [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    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.

  6. Explantation / deactivation / exchange information of the BIOMONITOR [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    Collect information about explantation, deactivation and exchanges of the BIOMONITOR, such as number, reason, and data on procedure.

  7. Adverse Events [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    Collect and analyze adverse events.

  8. Device Deficiencies [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    Collect and analyze device deficiencies. Calculate rate (frequency) of device deficiencies.

  9. Documentation of imaging techniques, if applied. [ Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). ]
    Documentation if patients underwent any MRI examinations or mammography. Documentation of exact kind of examination and occurrences with regard to the BIOMONITOR.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
Criteria

Inclusion Criteria:

  • Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM) or has received a BIOMONITOR III within the BIO|MASTER.BIOMONITOR III study
  • Patient is able to understand the nature of the registry and to provide written informed consent.
  • Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria:

  • Patient is pregnant or breast feeding.
  • Patient is less than 18 years old.
  • Patient is participating in another interventional clinical investigation other than the submodules of BIO|STREAM.ICM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075084


Contacts
Layout table for location contacts
Contact: Jens Buttgereit, Dr. +49 (0) 30 68905 1267 biomonitor-registry@biotronik.com
Contact: Sabrina Hoche, Dr. +49 (0) 30 68905 1337 biomonitor-registry@biotronik.com

Locations
Layout table for location information
Latvia
Pauls Stradins Clinical University Hospital Recruiting
Riga, Latvia, 1002
Sponsors and Collaborators
Biotronik SE & Co. KG
Layout table for additonal information
Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT04075084    
Other Study ID Numbers: HS061
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biotronik SE & Co. KG:
Implantable Cardiac Monitor
BIOMONITOR III
Additional relevant MeSH terms:
Layout table for MeSH terms
Syncope
Atrial Fibrillation
Tachycardia
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms