Clinical trial NCT04537455: Non-invasive Mapping Using Ultra-high Frequency Electrocardiography
Official title: Non-invasive Mapping Using Ultra-high Frequency Electrocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will have an ultra-high frequency electrocardiogram done.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients with block in the proximal conduction system
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital Imperial College NHS trust
Study officials:
affiliation: Imperial College London
name: Zachary Whinnett
role: STUDY_DIRECTOR
References:
citation: 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.