- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04138797
Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device (BIOSEMI-HV)
February 21, 2022 updated by: University Hospital, Bordeaux
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pessac, France, 33604
- Bordeaux University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients admitted at Bordeaux University Hospital for electrophysiological study with HV measurement.
Exclusion Criteria:
- Patients under 18 years old,
- Pregnant or breastfeeding women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electrophysiological exploration & ECG Biosemi
|
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 0
|
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
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Josselin DUCHATEAU, MD, University Hospital, Bordeaux
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2019
Primary Completion (Actual)
January 27, 2021
Study Completion (Actual)
January 27, 2021
Study Registration Dates
First Submitted
October 23, 2019
First Submitted That Met QC Criteria
October 23, 2019
First Posted (Actual)
October 25, 2019
Study Record Updates
Last Update Posted (Actual)
February 22, 2022
Last Update Submitted That Met QC Criteria
February 21, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHUBX 2019/11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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