Multimodality Assessment of Ventricular Scar Arrhythmogenicity.

NCT04632394 | Completed Results

• 1 other identifier: 2020.0237
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to improve our understanding of a life-threatening heart rhythm disorder known as ventricular tachycardia (VT). This is a disorder which originates from the lower chamber of the heart and frequently is associated with heart disease. We will use an MRI scan to generate a computer based model of the heart which can predict areas of the heart which are important in generating this rhythm disorder. We intend to assess how accurate this computer model is compared to traditional invasive assessment of the heart muscle. We also aim to assess the electrical characteristics of those areas which were predicted by the computer model in order to see why they were thought to be so important. All patients seen at St George's Hospital with VT will be eligible. As is routine for these patients, they will have an MRI scan of the heart. We will then use this scan to create a virtual reconstruction of the heart from which predictions of the critical areas of the heart which are generating the rhythm problem will be made. Then we will perform a VT ablation (studying the electrical properties and if necessary making a burn to treat the rhythm problem) - as per standard of care, however during the ablation we will spend extra time collecting information comparing the accuracy of the computer-generated model to the traditional invasive signals which guide ablation. We will study the electrical properties of those predicted areas to see what is special about them. The study will last up to three years.

Conditions

Ventricular Tachycardia

Keywords

ventricular tachycardia; ablation; cardiac MRI; computational modelling

Outcome Measures

Primary Outcomes (1)

• Electrogram Duration at Digital Twin Predicted Sites Compared to Non-predicted Sites

  Duration of electrograms at digital twin predicted sites compared to non-predicted sites on invasive mapping within areas of bipolar low voltage (\<1.5mV)

  During ablation

Secondary Outcomes (1)

• Symptom Assessment at 12 Month Clinical Follow up

  12 months

Study Arms (1)

Cases

Patients with scar-dependent ventricular tachycardia, requiring ablation. These patients will have satisfied the inclusion/exclusion criteria and be put forward for VT ablation. They will undergo the previously described study protocol, including generation of a computational model of the heart from their cardiac MRI and a VT ablation where we will study the points of interest generated from the MRI model in detail.

Diagnostic Test: Generation of computational model from cardiac MRI.; Procedure: VT ablation

Interventions

Generation of computational model from cardiac MRI. DIAGNOSTIC_TEST

Routine cardiac MRI scan results will be sent to Johns Hopkins University where a computer-generated model of the heart will be made, which will demonstrate predicted areas critical to VT generation and maintenance. This data will be sent back to St George's, and integrated with the standard VT ablation mapping software to allow comparison of its accuracy with standard mapping techniques.

Cases

VT ablation PROCEDURE

Routine VT ablation as described elsewhere in the literature. However, a brief period of extra time (\~30 minutes) will be spent analysing the areas of the heart which the MRI scan predicted as being important for generation of VT. We will study the effect of ablation of these areas (if indicated) on distant parts of the heart.

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study setting is a large tertiary centre hospital in London, St George's University Hospital which serves a population of around 1.3 million. It also receives referrals from district general hospitals in the surrounding area. Referrals are made to a specialist arrhythmia clinic from which suitable patients can be identified. The majority of recruited patients are expected to be outpatients who are symptomatic from VT despite optimal medical therapy. This will allow sufficient time to perform the cardiac MRI and to generate the computational model. In some scenarios, emergency admissions with symptomatic VT may be included if they are suitable for inpatient VT ablation and there is sufficient time for the MRI and computation analysis to take place prior to the VT ablation.

You may qualify if:

• Adult inpatients admitted to St George's Hospital London with sustained ventricular tachycardia or outpatients identified from the arrhythmia clinic with significant monomorphic ventricular tachycardia noted on cardiac monitoring who:
• Have sustained, monomorphic scar-dependent ventricular tachycardia
• Are symptomatic
• Failed, unable or unwilling to tolerate anti-arrhythmic medications
• Able to have a cardiac MRI
• Have a life expectancy \> 1 year
• At least 40 days following a myocardial infarction

You may not qualify if:

• Patients under the age of 18
• Patients who are unable to give informed consent
• Pregnant patients
• Unable to have cardiac MRI
• Prohibitive procedural risk
• Unable to tolerate the ablation procedure due to haemodynamic instability

Sponsors & Collaborators

• St George's, University of London: lead
• Johns Hopkins University: collaborator

Study Sites (1)

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Related Publications (1)

• Waight MC, Prakosa A, Li AC, Bunce N, Marciniak A, Trayanova NA, Saba MM. Personalized Heart Digital Twins Detect Substrate Abnormalities in Scar-Dependent Ventricular Tachycardia. Circulation. 2025 Feb 25;151(8):521-533. doi: 10.1161/CIRCULATIONAHA.124.070526. Epub 2025 Jan 6.

  PMID: 39758009 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Michael Waight
• Organization: St George's University of London

m2110065@citystgeorges.ac.uk

020 8672 9944

Study Officials

• Magdi Saba, MD

  St George's Hospital / SGUL

  STUDY DIRECTOR

• Anthony Li, MD

  St George's Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 17, 2020
• Study Start: March 1, 2021
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)