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Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Ultra-high frequency electrocardiography

About this trial

This is an interventional diagnostic trial for Left Bundle-Branch Block focused on measuring Ultra-high frequency electrocardiography, Left bundle branch block, Cardiac resynchronization Therapy, His Bundle Pacing

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Hammersmith Hospital Imperial College NHS trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abnormal cardiac conduction

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04537455

First Posted

August 28, 2020

Last Updated

March 21, 2023

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT04537455

Brief Title

Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

Official Title

Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

March 10, 2023 (Actual)

Study Completion Date

March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Patients will have an ultra-high frequency electrocardiogram done.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abnormal cardiac conduction

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Ultra-high frequency electrocardiography

Intervention Description

Patients will have an ultra-high frequency electrocardiography performed.

Primary Outcome Measure Information:

Title

Number of patients with block in the proximal conduction system

Description

number of participant with an electrical activation map where the pattern indicates proximal conduction disease.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zachary Whinnett

Organizational Affiliation

Imperial College London

Official's Role

Study Director

Facility Information:

Facility Name

Hammersmith Hospital Imperial College NHS trust

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28695377

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.

Results Reference

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Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

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