Dynamic Voltage Mapping to Personalise the Ventricular Tachycardia Substrate

NCT07573579 | Not Yet Recruiting

• 2 other identifiers: 35371FS/CRTF/25/24865
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder and one of the commonest causes of heart-related sudden death. It often affects people who have had a heart attack or other structural heart damage. VT occurs when abnormal electrical circuits develop within and around scar tissue in the heart. People at risk are usually offered an implantable cardiac defibrillator (ICD), a device that can detect VT and deliver a lifesaving shock. While effective, these shocks can be sudden, painful and distressing. Medications such as amiodarone can also help, but they are often unsuitable for long-term use due to their potential side effects on the liver, lungs and thyroid gland. An alternative is catheter ablation. Thin tubes (catheters) are threaded from a blood vessel in the groin to the heart, allowing the cardiologist to identify scar tissue and abnormal electrical circuits, which can be destroyed using heat, freezing or electrical energy. Although ablation can help many patients, VT can return in up to one in three people after the procedure. This is because it can be difficult to precisely identify the scar and surrounding tissue that sustain the abnormal circuits, making it challenging to know exactly where to apply ablation treatment. Dynamic Voltage Mapping, is a technique which the investigators believe can more accurately identify scar and the critical bordering tissue during ablation. Initial data collected suggests that the approach accurately predicts the VT circuit and helps guide ablation. In this study, the investigators wish to recruit 40 participants undergoing VT ablation to determine how effective Dynamic Voltage Mapping is in real-world procedures.

Conditions

Ventricular Tachycardia (VT)

Keywords

Catheter Ablation; Electroanatomical Mapping; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Study Feasibility

  1. Proportion of screened patients who were eligible, approached, consented and recruited 2. Attrition rate: calculated as the total number of recruited patients who withdrew from the study or were lost to follow up 3. Adherence: calculated as the proportion of recruited participants who were able to fully follow the study protocol in both DVM and standard of care arms during their VT ablation procedure.

  From enrolment to end of follow up (1 year after procedure)

Secondary Outcomes (4)

• Procedural Time

  From start of procedure to end (skin-to-skin)

• Ablation time/number of lesions

  From start of procedure to end (skin-to-skin)

• Acute VT non-inducibility

  From start of procedure to end (skin-to-skin)

• VT recurrence Rate

  From end of procedure to end of follow up (12 months)

Study Arms (2)

Dynamic Voltage Mapping Guided Ablation

EXPERIMENTAL

Patients assigned to this group will have Dynamic Voltage Maps available for the operator to view during the procedure to help guide ablation.

Procedure: Dynamic Voltage Mapping

Standard of Care Ablation

ACTIVE COMPARATOR

Patients assigned to this group will receive standard of care ablation, and operators will be blinded to Dynamic Voltage Maps created during the procedure.

Procedure: Standard of Care Ablation

Interventions

Dynamic Voltage Mapping PROCEDURE

Dynamic Voltage Mapping uses electrical information collected from catheters positioned within the heart to create an individualised map of the heart, which the investigators hypothesise will better identify scar and surrounding tissue responsible for ventricular tachycardia.

Also known as: DVM, Dynamic Voltage Map

Dynamic Voltage Mapping Guided Ablation

Standard of Care Ablation PROCEDURE

Standard catheter ablation of ventricular tachycardia, guided by operator preference

Also known as: Catheter ablation

Standard of Care Ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for clinically indicated VT ablation (due to sustained VT episodes or ICD therapies).
• Willing and able to give informed consent for participation in the trial
• Male or female aged between 18-85
• Ischaemic and non-ischaemic cardiomyopathy
• ICD insitu

You may not qualify if:

• Unable or unwilling to consent
• NYHA Class IV (end stage heart failure)
• Metastatic cancer
• End stage renal disease
• Pregnant or breast feeding
• Severe frailty

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead

Study Sites (1)

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, L14 3PE, United Kingdom

Location

Related Publications (3)

• Grade Santos J, Mills MT, Calvert P, Worthington N, Phenton C, Modi S, Ashrafi R, Todd D, Waktare J, Mahida S, Gupta D, Luther V. Delineating postinfarct ventricular tachycardia substrate with dynamic voltage mapping in areas of omnipolar vector disarray. Heart Rhythm O2. 2024 Feb 27;5(4):224-233. doi: 10.1016/j.hroo.2024.02.006. eCollection 2024 Apr.

  PMID: 38690145 BACKGROUND

• Khanra D, Calvert P, Hughes S, Waktare J, Modi S, Hall M, Todd D, Mahida S, Gupta D, Luther V. An approach to help differentiate postinfarct scar from borderzone tissue using Ripple Mapping during ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2023 Mar;34(3):664-672. doi: 10.1111/jce.15766. Epub 2023 Jan 12.

  PMID: 36478627 BACKGROUND

• Mills MT, Calvert P, Chiong J, Gupta D, Luther V. Dynamic Voltage Mapping of the Post-infarct Ventricular Tachycardia Substrate: A Practical Technique to Help Differentiate Scar from Borderzone Tissue. Arrhythm Electrophysiol Rev. 2024 Oct 14;13:e16. doi: 10.15420/aer.2024.26. eCollection 2024.

  PMID: 39507206 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
• Access Criteria: De-identified individual participant data and supporting documents (study protocol, statistical analysis plan, and analytic code) will be available to qualified researchers for scientifically sound proposals. Access will be granted upon reasonable request to the study's Chief Investigator, subject to review and approval by the sponsor and in accordance with institutional and regulatory requirements. Data will be shared under a formal data sharing agreement, and access will be provided via a secure data transfer method or controlled-access environment.

Locations

GB (1)