Tachycardia AtrialNCT04198220
BIO|STREAM.ICM Obesity
An observational study of Tachycardia Atrial and Atrial Fibrillation, run by Biotronik SE & Co. KG at 1 site in Italy.
Trial summary
The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia Atrial, Atrial Fibrillation, Syncope
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population consists of obese patients (BMI > 30 kg/m2) with an implantable cardiac monitor
Who may be able to join
- Patient is already enrolled in the BIO|STREAM.ICM registry
- Patient BMI > 30
Who cannot join
- Patient clinically indicated for or already implanted with another cardiac active device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry
The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.
Read the detailed description
This submodule of the BIO|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI >30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.
- Keywords
- Obesity, BIOMONITOR, BIOMONITOR III, Syncope, Cryptogenic stroke, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation, Syncope, Bradycardia, Ischemic Stroke, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
R-wave amplitude
R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI > 30
Measured: 3 month
Secondary outcomes (2)
Amount of 'noise burden'
Measurement of amount of 'noise burden' during the study period
Measured: 3 month
P-wave visibility
Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation
Measured: 1 month and 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start17 Sep 2020
- Primary completion26 May 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tachycardia AtrialStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Bisignani, Dr., Principal investigator, Ospedale Civile Ferrari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198220
- Sponsor's protocol ID
- HS064
- Status last verified
- Dec 2020
- First submitted
- 12 Dec 2019
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37025684
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|STREAM.ICM Obesity, Submodule of the BIO|STREAM.ICM Registry
- ClinicalTrials.gov ID
- NCT04198220
- Acronym / sponsor ID
- HS064
- Keywords
- Obesity, BIOMONITOR, BIOMONITOR III, Syncope, Cryptogenic stroke, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.
Detailed description
This submodule of the BIO|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI >30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population consists of obese patients (BMI > 30 kg/m2) with an implantable cardiac monitor
Key inclusion criteria (2 listed)
- Patient is already enrolled in the BIO|STREAM.ICM registry
- Patient BMI > 30
Key exclusion criteria (1 listed)
- Patient clinically indicated for or already implanted with another cardiac active device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
R-wave amplitude
Time frame: 3 month
R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI > 30
2 secondary outcomes
Amount of 'noise burden'
Time frame: 3 month
P-wave visibility
Time frame: 1 month and 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Derived from this study: PubMed 37025684Bisignani 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.
- Individual participant dataSharing planned: No
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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.
Giovanni Bisignani, Dr. principal investigator
Ospedale Civile Ferrari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia Atrial and Atrial Fibrillation, run by Biotronik SE & Co. KG at 1 site in Italy.
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 2 inclusion and 1 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 22 Oct 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
R-wave amplitude (time frame: 3 month). 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 NCT04198220, which also lists 1 linked publication.
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 22 Oct 2021.