- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07573579
Dynamic Voltage Mapping to Personalise the Ventricular Tachycardia Substrate (DYNAMITE-VT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Liverpool, United Kingdom, L14 3PE
- Liverpool Heart and Chest Hospital NHS Foundation Trust
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Contact:
- Vishal Luther, MRCP PhD ECES ECDS
- Phone Number: 0151 600 1251
- Email: vishal.luther@lhch.nhs.uk
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Contact:
- Justin Chiong, MBChB MSc MRCP
- Email: justin.chiong@lhch.nhs.uk
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Principal Investigator:
- Vishal Luther, MRCP PhD ECES ECDS
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Sub-Investigator:
- Justin Chiong, MBChB MSc MRCP
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable or unwilling to consent
- NYHA Class IV (end stage heart failure)
- Metastatic cancer
- End stage renal disease
- Pregnant or breast feeding
- Severe frailty
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dynamic Voltage Mapping Guided Ablation
Patients assigned to this group will have Dynamic Voltage Maps available for the operator to view during the procedure to help guide ablation.
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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.
Other Names:
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Active Comparator: Standard of Care Ablation
Patients assigned to this group will receive standard of care ablation, and operators will be blinded to Dynamic Voltage Maps created during the procedure.
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Standard catheter ablation of ventricular tachycardia, guided by operator preference
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Study Feasibility
Time Frame: From enrolment to end of follow up (1 year after procedure)
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From enrolment to end of follow up (1 year after procedure)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Procedural Time
Time Frame: From start of procedure to end (skin-to-skin)
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Measured in minutes
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From start of procedure to end (skin-to-skin)
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Ablation time/number of lesions
Time Frame: From start of procedure to end (skin-to-skin)
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Measured by number of ablation lesions applied
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From start of procedure to end (skin-to-skin)
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Acute VT non-inducibility
Time Frame: From start of procedure to end (skin-to-skin)
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Ability to induce clinical VT at the end of the procedure
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From start of procedure to end (skin-to-skin)
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VT recurrence Rate
Time Frame: From end of procedure to end of follow up (12 months)
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Number of sustained VT episodes/ICD shocks/therapies following procedure, recorded by implanted cardiac device
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From end of procedure to end of follow up (12 months)
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiac Conduction System Disease
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Arrhythmias, Cardiac
- Tachycardia
- Pathological Conditions, Signs and Symptoms
- Tachycardia, Ventricular
- Therapeutics
- Surgical Procedures, Operative
- Ablation Techniques
- Radiofrequency Ablation
- Radiofrequency Therapy
- Catheter Ablation
Other Study ID Numbers
- 35371
- FS/CRTF/25/24865 (Other Grant/Funding Number: British Heart Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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