Cardiac ElectrophysiologyBIOSEMI-HVNCT04138797
Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device
A study testing Electrophysiological exploration and ECG Biosemi in people with Cardiac Electrophysiology and Electrocardiogram, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
His-Ventricle (HV) measurement is only obtained invasively using transvenous catheters. This kind of procedure is routinely performed but some risks of complication exist. HV interval prolongation is correlated with increased risk of occurrence of complete atrioventricular block which could lead to syncope or cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Electrophysiology, Electrocardiogram
- What is being tested?
- Electrophysiological exploration and ECG Biosemi
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2019to 27 Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients admitted at Bordeaux University Hospital for electrophysiological study with HV measurement.
Who cannot join
- Patients under 18 years old,
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
His-Ventricle (HV) measurement is only obtained invasively using transvenous catheters. This kind of procedure is routinely performed but some risks of complication exist. HV interval prolongation is correlated with increased risk of occurrence of complete atrioventricular block which could lead to syncope or cardiac sudden death. A new non invasive, high density and high fidelity system (BioSemi, BioSemi B.V., Amsterdam, Netherlands) can theorically collect such electrophysiological signal using a signal averaging acquisition method. We want to assess the possibility of non invasive HV interval measurement using this new device.
- Conditions
- Cardiac Electrophysiology, Electrocardiogram
- Being tested
- Electrophysiological exploration, ECG Biosemi
- Keywords
- Signal Averaging ECG, HV interval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological explorationProcedure or surgery
Electrophysiological exploration is performed, as part of the routine care, after the Biosemi high density ECG, the same day or maximum 4 days later. It is performed in interventional rhythmology room, under fluoroscopic control. After local anesthesia, one or more introducers are placed in the femoral vein allowing the introduction of catheters. These catheters allow recording of the HV interval
ECG BiosemiDevice
Non invasive ECG monitoring for HV measurement using high density Biosemi device. This device use 256 skin electrodes. At the same time and with the same system, a chest pressure sensor can record the patient's breathing movements.
| Study group | Role | What they receive |
|---|---|---|
| Electrophysiological exploration & ECG Biosemi | Experimental | Not described Receives: Procedure: Electrophysiological exploration; Device: ECG Biosemi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of HV interval correlation by the intra-class correlation coefficient
The correlation of the HV interval obtained using the 2 different methods, is measured by a correlation coefficient
Measured: Day 0
Measurement of HV interval correlation by graphical representation
The correlation of the HV interval obtained using the 2 different methods, is measured by a graphical representation of Bland and Altman
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start7 Oct 2019
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ElectrophysiologyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josselin DUCHATEAU, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138797
- Sponsor's protocol ID
- CHUBX 2019/11
- Acronym
- BIOSEMI-HV
- Status last verified
- Feb 2022
- First submitted
- 23 Oct 2019
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device
- ClinicalTrials.gov ID
- NCT04138797
- Acronym / sponsor ID
- BIOSEMI-HV / CHUBX 2019/11
- Conditions
- Cardiac Electrophysiology, Electrocardiogram
- Keywords
- Signal Averaging ECG, HV interval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 25 Oct 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.
His-Ventricle (HV) measurement is only obtained invasively using transvenous catheters. This kind of procedure is routinely performed but some risks of complication exist. HV interval prolongation is correlated with increased risk of occurrence of complete atrioventricular block which could lead to syncope or cardiac sudden death. A new non invasive, high density and high fidelity system (BioSemi, BioSemi B.V., Amsterdam, Netherlands) can theorically collect such electrophysiological signal using a signal averaging acquisition method. We want to assess the possibility of non invasive HV interval measurement using this new device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrophysiological exploration & ECG Biosemi | Experimental | Procedure: Electrophysiological exploration, Device: ECG Biosemi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted at Bordeaux University Hospital for electrophysiological study with HV measurement.
Key exclusion criteria (2 listed)
- Patients under 18 years old,
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Electrophysiological explorationElectrophysiological exploration is performed, as part of the routine care, after the Biosemi high density ECG, the same day or maximum 4 days later. It is performed in interventional rhythmology room, under fluoroscopic control. After local anesthesia, one or more introducers are placed in the femoral vein allowing the introduction of catheters. These catheters allow recording of the HV interval | Procedure or surgery | Electrophysiological exploration & ECG Biosemi |
| ECG BiosemiNon invasive ECG monitoring for HV measurement using high density Biosemi device. This device use 256 skin electrodes. At the same time and with the same system, a chest pressure sensor can record the patient's breathing movements. | Device | Electrophysiological exploration & ECG Biosemi |
Primary outcome
Measurement of HV interval correlation by the intra-class correlation coefficient
Time frame: Day 0
The correlation of the HV interval obtained using the 2 different methods, is measured by a correlation coefficient
Measurement of HV interval correlation by graphical representation
Time frame: Day 0
The correlation of the HV interval obtained using the 2 different methods, is measured by a graphical representation of Bland and Altman
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 Feb 2022.
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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.
Josselin DUCHATEAU, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiological exploration and ECG Biosemi in people with Cardiac Electrophysiology and Electrocardiogram, run by University Hospital, Bordeaux at 1 site in France.
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 1 inclusion and 2 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 Feb 2022. 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 France. 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?
Measurement of HV interval correlation by the intra-class correlation coefficient (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2022.