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| ID | Type | Description | Link |
|---|---|---|---|
| FS/CRTF/25/24865 | Other Grant/Funding Number | British Heart Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility |
| From enrolment to end of follow up (1 year after procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Time | Measured in minutes | From start of procedure to end (skin-to-skin) |
| Ablation time/number of lesions | Measured by number of ablation lesions applied |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Heart and Chest Hospital NHS Foundation Trust | Liverpool | L14 3PE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38690145 | Background | 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. | |
| 36478627 |
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De-identified individual participant data underlying the results reported in publications (including baseline characteristics, procedural data, and outcome measures). Additional data may be available upon reasonable request, subject to institutional approvals and data sharing agreements.
IPD and supporting information will be available beginning 6 months after publication of the primary results and will remain available for 5 years thereafter.
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.
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
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| Standard of Care Ablation | Procedure | Standard catheter ablation of ventricular tachycardia, guided by operator preference |
|
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| From start of procedure to end (skin-to-skin) |
| Acute VT non-inducibility | Ability to induce clinical VT at the end of the procedure | From start of procedure to end (skin-to-skin) |
| VT recurrence Rate | Number of sustained VT episodes/ICD shocks/therapies following procedure, recorded by implanted cardiac device | From end of procedure to end of follow up (12 months) |
| 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. |
| 39507206 | 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. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |