Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

NCT ID: NCT04537455

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2024-03-10

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients will have an ultra-high frequency electrocardiogram done.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Abnormal cardiac conduction

patients with abnormal cardiac conduction will undergo an ultra-high frequency electrocardiogram

Group Type EXPERIMENTAL

Ultra-high frequency electrocardiography

Intervention Type DIAGNOSTIC_TEST

Patients will have an ultra-high frequency electrocardiography performed.

Interventions

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Ultra-high frequency electrocardiography

Patients will have an ultra-high frequency electrocardiography performed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zachary Whinnett

Role: STUDY_DIRECTOR

Imperial College London

Locations

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Hammersmith Hospital Imperial College NHS trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 28695377 (View on PubMed)

Other Identifiers

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19HH5155

Identifier Type: -

Identifier Source: org_study_id

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