Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

NCT04537455 | Completed

• 1 other identifier: 19HH5155
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Abnormal cardiac conduction

EXPERIMENTAL

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

Diagnostic Test: Ultra-high frequency electrocardiography

Interventions

Ultra-high frequency electrocardiography DIAGNOSTIC_TEST

Patients will have an ultra-high frequency electrocardiography performed.

Abnormal cardiac conduction

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give consent
• Children (age \< 18 years)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital Imperial College NHS trust

London, W12 0HS, United Kingdom

Location

Related 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.

  PMID: 28695377 BACKGROUND

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zachary Whinnett

  Imperial College London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will have an ultra-high frequency electrocardiogram done.

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 3, 2020
• Study Start: October 1, 2019
• Primary Completion: December 10, 2023
• Study Completion: March 10, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)