Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

Left Bundle-Branch Block Clinical Trial

Official title:

Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537455
• Other study ID #: 19HH5155
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 10, 2024

Study information

• Verified date: April 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 10, 2024
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Unable to give consent

• Children (age < 18 years)

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Block
• Left Bundle-Branch Block
• Non-Specific Intraventricular Conduction Defect
• Right Bundle-Branch Block

Intervention

Diagnostic Test:
• Ultra-high frequency electrocardiography
Patients will have an ultra-high frequency electrocardiography performed.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital Imperial College NHS trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years