Left Bundle-Branch BlockNCT04537455
Non-invasive Mapping Using Ultra-high Frequency Electrocardiography
A study testing Ultra-high frequency electrocardiography in people with Left Bundle-Branch Block and Right Bundle-Branch Block, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Cardiac electrical mapping is an important tool that allows doctors to study the electrical activity of the heart in detail. Electrical mapping systems used in clinical practice are time consuming, invasive and very costly. Ultra-high frequency electrocardiography is a novel non-invasive cardiac mapping system. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Bundle-Branch Block, Right Bundle-Branch Block, Non-Specific Intraventricular Conduction Defect
- What is being tested?
- Ultra-high frequency electrocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2019to 10 Mar 2024
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (age > 18 years)
- Able to give consent
- Some patients will be recruited from those listed for a clinically indicated VT ablation
- Patient subgroups as follows; 60 participants with LBBB undergoing a clinically indicated VT ablation , 20 participants with normal 12 lead ECG and normal left ventricular function assessed using standard echocardiography, 20 participants with right bundle branch block morphology on 12 lead ECG, 40 participants with non-specific conduction delay on 12 lead ECG, 60 participants with left bundle branch block morphology on 12 lead ECG and 20 participants who developed left bundle branch block morphology on 12 lead ECG after undergoing aortic valve replacement
Who cannot join
- Unable to give consent
- Children (age < 18 years)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Hospital Imperial College NHS trust
London, W12 0HS
About this study
Cardiac electrical mapping is an important tool that allows doctors to study the electrical activity of the heart in detail. Electrical mapping systems used in clinical practice are time consuming, invasive and very costly. Ultra-high frequency electrocardiography is a novel non-invasive cardiac mapping system. Ultra-high frequency electrocardiography (UHF-ECG) can be performed in 10-15 minutes without any risk or discomfort to patients.
The aim of this study is to refine this mapping system, verify it against invasive mapping and develop software to bring this novel system into routine clinical use including predicting which patients will respond to cardiac resynchronisation therapy.
Read the detailed description
This is a single centre laboratory study aiming to utilise ultra-high frequency electrocardiography to construct cardiac electrical activation maps.
All participants will attend for an UHF-ECG. This involves placing standard electrocardiography electrodes (up to 48) followed by electrocardiography recording using the UHF-ECG machine for 10-15 minutes.
Participants undergoing a clinically indicated VT ablation procedure will their UHF-ECG done before the procedure at a separate time. The ablation procedure itself will proceed as standard with no alternation whatsoever in study participants and no invasive measurements will be undertaken during the procedure. After the procedure is complete the 3D electrical maps collected to guide VT ablation will be analyzed and used for the study. The invasive maps will be compared with the non-invasive maps obtained using UHF-EGC.
- Conditions
- Left Bundle-Branch Block, Right Bundle-Branch Block, Non-Specific Intraventricular Conduction Defect
- Being tested
- Ultra-high frequency electrocardiography
- Keywords
- Ultra-high frequency electrocardiography, Left bundle branch block, Cardiac resynchronization Therapy, His Bundle Pacing
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-high frequency electrocardiographyDiagnostic test
Patients will have an ultra-high frequency electrocardiography performed.
| Study group | Role | What they receive |
|---|---|---|
| Abnormal cardiac conduction | Experimental | patients with abnormal cardiac conduction will undergo an ultra-high frequency electrocardiogram Receives: Diagnostic Test: Ultra-high frequency electrocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with block in the proximal conduction system
number of participant with an electrical activation map where the pattern indicates proximal conduction disease.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Oct 2019
- Primary completion10 Dec 2023
- Study completion10 Mar 2024
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 Left Bundle-Branch BlockStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Model description
- Patients will have an ultra-high frequency electrocardiogram done.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zachary Whinnett, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537455
- Sponsor's protocol ID
- 19HH5155
- Status last verified
- Apr 2024
- First submitted
- 28 Aug 2020
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jurak P, Halamek J, Meluzin J, Plesinger F, Postranecka T, Lipoldova J, Novak M, Vondra V, Viscor I, Soukup L, Klimes P, Vesely P, Sumbera J, Zeman K, Asirvatham RS, Tri J, Asirvatham SJ, Leinveber P. Ventricular dyssynchrony assessment using ultra-high frequency ECG technique. J Interv Card Electrophysiol. 2017 Sep;49(3):245-254. doi: 10.1007/s10840-017-0268-0. Epub 2017 Jul 10.
PubMed 28695377
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Mapping Using Ultra-high Frequency Electrocardiography
- ClinicalTrials.gov ID
- NCT04537455
- Acronym / sponsor ID
- 19HH5155
- Conditions
- Left Bundle-Branch Block, Right Bundle-Branch Block, Non-Specific Intraventricular Conduction Defect
- Keywords
- Ultra-high frequency electrocardiography, Left bundle branch block, Cardiac resynchronization Therapy, His Bundle Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 3 Sep 2020 (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.
Cardiac electrical mapping is an important tool that allows doctors to study the electrical activity of the heart in detail. Electrical mapping systems used in clinical practice are time consuming, invasive and very costly. Ultra-high frequency electrocardiography is a novel non-invasive cardiac mapping system. Ultra-high frequency electrocardiography (UHF-ECG) can be performed in 10-15 minutes without any risk or discomfort to patients.
The aim of this study is to refine this mapping system, verify it against invasive mapping and develop software to bring this novel system into routine clinical use including predicting which patients will respond to cardiac resynchronisation therapy.
Detailed description
This is a single centre laboratory study aiming to utilise ultra-high frequency electrocardiography to construct cardiac electrical activation maps.
All participants will attend for an UHF-ECG. This involves placing standard electrocardiography electrodes (up to 48) followed by electrocardiography recording using the UHF-ECG machine for 10-15 minutes.
Participants undergoing a clinically indicated VT ablation procedure will their UHF-ECG done before the procedure at a separate time. The ablation procedure itself will proceed as standard with no alternation whatsoever in study participants and no invasive measurements will be undertaken during the procedure. After the procedure is complete the 3D electrical maps collected to guide VT ablation will be analyzed and used for the study. The invasive maps will be compared with the non-invasive maps obtained using UHF-EGC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will have an ultra-high frequency electrocardiogram done.
| Arm | Type | Receives |
|---|---|---|
| Abnormal cardiac conduction | Experimental | Diagnostic Test: Ultra-high frequency electrocardiographypatients with abnormal cardiac conduction will undergo an ultra-high frequency electrocardiogram |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (age > 18 years)
- Able to give consent
- Some patients will be recruited from those listed for a clinically indicated VT ablation
- Patient subgroups as follows; 60 participants with LBBB undergoing a clinically indicated VT ablation , 20 participants with normal 12 lead ECG and normal left ventricular function assessed using standard echocardiography, 20 participants with right bundle branch block morphology on 12 lead ECG, 40 participants with non-specific conduction delay on 12 lead ECG, 60 participants with left bundle branch block morphology on 12 lead ECG and 20 participants who developed left bundle branch block morphology on 12 lead ECG after undergoing aortic valve replacement
Key exclusion criteria (2 listed)
- Unable to give consent
- Children (age < 18 years)
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 |
|---|---|---|
| Ultra-high frequency electrocardiographyPatients will have an ultra-high frequency electrocardiography performed. | Diagnostic test | Abnormal cardiac conduction |
Primary outcome
Number of patients with block in the proximal conduction system
Time frame: 3 years
number of participant with an electrical activation map where the pattern indicates proximal conduction disease.
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 23 Apr 2024.
- Background: PubMed 28695377Jurak P, Halamek J, Meluzin J, Plesinger F, Postranecka T, Lipoldova J, Novak M, Vondra V, Viscor I, Soukup L, Klimes P, Vesely P, Sumbera J, Zeman K, Asirvatham RS, Tri J, Asirvatham SJ, Leinveber P. Ventricular dyssynchrony assessment using ultra-high frequency ECG technique. J Interv Card Electrophysiol. 2017 Sep;49(3):245-254. doi: 10.1007/s10840-017-0268-0. Epub 2017 Jul 10.
- 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.
Zachary Whinnett study director
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-high frequency electrocardiography in people with Left Bundle-Branch Block and Right Bundle-Branch Block, run by Imperial College London at 1 site in United Kingdom.
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 4 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 23 Apr 2024. 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 United Kingdom. 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?
Number of patients with block in the proximal conduction system (time frame: 3 years). 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 NCT04537455, 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 23 Apr 2024.