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Not yet recruitingNCT05500365Updated Mar 13, 2023

In Silico Pace Mapping To Optimise Ventricular Tachycardia Ablation

An observational study in Ventricular Tachycardia, sponsored by Guy's and St Thomas' NHS Foundation Trust. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-03-13.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 99 Years
Sex
All
01

Study summary

People who suffer from incessant cardiac arrhythmias receive a small electrical device implanted into their chest that automatically senses when the heart beats arrhythmically and applies electrical pulse to re-establish normal activity. However, if problems persist, people can have an operation called catheter ablation therapy, which involves 'burning' small areas of the heart tissue in order to permanently disrupt the problematic electrical pathways driving these arrhythmias.

However, procedure times and complication rates are high, whist success rates are punitively low (\~50% success), largely due to the significant challenge clinicians face in identifying the ideal 'target' to ablate within the patient's heart. In this project, the investigators aim to develop, and clinically validate, an in silico tool that reconstructs a personalised computational model of a patient's heart using advanced MRI data, upon which a virtual 'mapping' procedure is then performed in order to identify (in the model) the optimal ablation target. This pre-procedural planning tool utilises stored information about the patient's specific arrhythmia from their implanted device, ensuring optimal targets are selected. The approach aims to reduce procedure times whilst increasing their safety, and ensure significantly increased long-term effectiveness of these invasive ablation procedures, increasing survival rates and quality-of-life.

This study is concerned with the clinical arm of the study, specifically, in the collection of data from patients in order to (retrospectively) validate the computational model. The model itself will not be applied or used to treat these patients.

Read the detailed description

Catheter ablation of ventricular tachycardia (VT) most frequently requires the identification of exit sites of slow-conducting diastolic isthmuses associated with infarcted tissue which are critical to sustain the reentrant arrhythmia. Pace mapping is a technique that identifies exit sites by matching the recorded 12-lead electrocardiogram (ECG) QRS of catheter-paced beats at different myocardial locations with the QRS of the clinical VT. When a high correlation between QRS morphologies is found, it is believed that the paced-beat lies at the VT exit site, helping guide the ablation. Procedures thus involve methodologically moving the catheter to multiple (accessible) locations to produce a pace map. Unfortunately the procedure is inherently limited due to the following reasons:

i) Surface maps - Most often, pacing sites are limited to the endocardium (where catheter access is easiest). Consequently, identification of VTs with an intramural or epicardial substrate can be challenging, with mis-leading and/or difficult to interpret pace maps being obtained.

ii) Low Resolution - Due to time-pressures and practical difficulties in catheter manipulation, pace map sites are often sparsely located (typically 40-60 separate sites). In complex structural VTs, with multiple possible anatomical circuits through the scar, it is often challenging to accurately identify from the map the relevant isthmus exit site responsible for the presenting clinical VT.

iii) VT Induction - Pace mapping usually necessitates VT induction during the procedure, which is time-consuming and carries inherent risk (\~80% of induced VTs in ischemic heart disease (IHD) are either non-sustained or not haemodynamically tolerated), but induction of the exact clinical VT itself is often challenging.

A non-invasive, pre-procedural approach that is capable of generating accurate, high-resolution 3-dimensional personalised pace maps that correlate with the presenting clinical VT without the need for VT induction would thus revolutionise VT ablation planning, guidance, safety and efficacy.

Two recent studies have demonstrated the utility of performing a pace map based on comparison to stored implanted cardioverter defibrillator (ICD) electrograms (EGMs) of the clinical VT. The first study initially demonstrated that stored ICD EGMs allow differentiation of the clinical VT from other VTs, and their subsequent use in pace mapping may be useful for identifying the VT exit site. More recently, it has been prospectively shown that pace mapping of non-inducible clinical VTs based on ICD EGMs is feasible and resulted in higher freedom from recurrent VT, compared to targeting only inducible VTs.

The investigators have recently published a pipeline for creating a patient-specific image-based whole torso-cardiac model to perform virtual ('in silico') pace mapping. The approach creates a high-resolution 3D pace map that successfully identifies the exit site of an induced (simulated) VT within the same model, using both simulated 12-lead ECG and ICD EGM data derived from the simulated VT episode. Here, it was demonstrated: 1) the importance of creating a dense, fully transmural (3D) pace map to allow differentiation of epicardial vs endocardial substrates; 2) that accuracy of exit site identification could be enhanced by considering multiple EGM sensing vectors, e.g. from multipolar cardiac resynchronisation devices (CRT-D) with additional epicardial electrodes. Developed on simulated data, this workflow now requires full validation with clinical data from ablation patients, as proposed here, and refinement of methodological algorithms.

02

Conditions studied

  • Ventricular Tachycardia

Keywords

  • Catheter Ablation
  • Pace Mapping
03

In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's planned enrollment of 25 is below the median of 149 across 208 observational studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Ischemic cardiomyopathy suffering from refractory ventricular tachycardia

Inclusion criteria

  • Age 18 to 99 years
  • Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
  • Ventricular tachycardia secondary to ischemic heart disease clinically indicated for catheter ablation therapy
  • Cardiac implanted electronic device in situ

Exclusion criteria

Exclusion Criteria:

  1. Standard contra-indications to VT ablation
  2. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  3. Contra-indication to contrast agent for Cardiac MRI scan
  4. Implanted device that is not MRI-conditional
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • ProcedureCatheter ablation therapy

    Pace mapping procedure performed during catheter ablation therapy

06

What researchers measure

Primary outcomes

  1. Performance of in silico derived pace map

    The primary outcome measure will be the geometrical distance between the exit site (site of highest correlation) identified from the in silico pace map (created from the collected patient data) and the actual pace map derived from the patient.

    Time frame: At the time of the procedure.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Yoshida K, Liu TY, Scott C, Hero A, Yokokawa M, Gupta S, Good E, Morady F, Bogun F. The value of defibrillator electrograms for recognition of clinical ventricular tachycardias and for pace mapping of post-infarction ventricular tachycardia. J Am Coll Cardiol. 2010 Sep 14;56(12):969-79. doi: 10.1016/j.jacc.2010.04.043. PubMed 20828650 ↗
  • Yokokawa M, Kim HM, Sharaf Dabbagh G, Siontis KC, Lathkar-Pradhan S, Jongnarangsin K, Latchamsetty R, Morady F, Bogun F. Targeting Noninducible Clinical Ventricular Tachycardias in Patients With Prior Myocardial Infarctions Based on Stored Electrograms. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e006978. doi: 10.1161/CIRCEP.118.006978. Epub 2019 Jun 20. PubMed 31216885 ↗
  • Monaci S, Strocchi M, Rodero C, Gillette K, Whitaker J, Rajani R, Rinaldi CA, O'Neill M, Plank G, King A, Bishop MJ. In-silico pace-mapping using a detailed whole torso model and implanted electronic device electrograms for more efficient ablation planning. Comput Biol Med. 2020 Oct;125:104005. doi: 10.1016/j.compbiomed.2020.104005. Epub 2020 Sep 17. PubMed 32971325 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05500365
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
Responsible party
Sponsor
First posted
Aug 15, 2022
Start date
Oct 1, 2023 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Mar 13, 2023

Study contacts

Martin Bishop, DPhil
Contact
martin.bishop@kcl.ac.uk
+44 20 7188 7188 ext. 53219
Aldo Rinaldi, MD
principal investigator · St Thomas' Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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