An interventional study of Ripple Mapping guided ischaemic VT ablation in Ventricular Tachycardia and Ischemic Heart Disease, sponsored by Imperial College Healthcare NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by Imperial College Healthcare NHS Trust · Not applicable, Interventional, and Treatment
The Ripple VT-1 Study is a prospective clinical trial that aims to investigate if catheter ablation of ventricular tachycardia in patients with ischaemic heart disease can be effectively performed using Ripple Mapping.
Patients who have ischaemic heart disease and are at sufficient risk of, or have suffered, ventricular tachycardia may receive implantable cardioverter defibrillator (ICD) devices. ICD devices provide life-saving shocks to terminate ventricular tachycardia. There is however substantial evidence that correlates each life-saving shock with worsening prognosis.
Catheter ablation is a procedure that can treat the cause of ischaemic ventricular tachycardia (VT). Most catheter ablation procedures for ischaemic VT are performed in normal rhythm, with an end-point of arrhythmic substrate modification. Arrhythmic substrate modification refers to the process by which abnormal electrical activity in cardiac scar tissue (from ischaemic heart disease) is identified and treated by ablation.
Substrate modification catheter ablation procedures for ischaemic VT have been demonstrated to reduce ICD shocks and VT episodes in randomised trials compared to medications. However, ablation procedure outcomes are still imperfect with a recurrence rate of 50-60%.
Ripple Mapping is a method of mapping the hearts electrical signals, that may allow better identification of the abnormal activity within scar and so improve recurrence rates following ablation.
Patients referred for ablation of ischaemic VT, who have an ICD, will undergo their procedure with Ripple Mapping and subsequently followed up over a year, at 3 monthly intervals. The main assessed outcome will be ICD or VT events over a year. This will be compared to the number of ICD or VT events the year prior to ablation.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Imperial College Healthcare NHS Trust is the lead sponsor of 79 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Patients referred for ablation of ischaemic VT undergo Ripple Mapping guided procedure.
Procedure: Ripple Mapping guided ischaemic VT ablation
Endocardial mapping of the ventricle performed with Ripple Mapping (CARTO3v6, Biosense Webster Inc). Ablation (SmarTouch Thermocool Catheter, Biosense Webster Inc) delivered to areas of abnormal "late" electrical activity within ventricular scar tissue.
Combined ICD Therapies and Mortality
ICD therapy (ATP and shocks) for sustained ventricular tachycardia or ventricular fibrillation as documented by the patients device. Device interrogations occur 3 monthly. Combined with Mortality (all-cause) by 1 year.
Time frame: 12 months
Achievement of the ablation procedure protocol end-point
Abolition of abnormal electrical activity within ischaemic ventricular scar by Ripple Mapping guided ablation
Time frame: Procedure
Total ICD therapy rate
Total appropriate and inappropriate (defined as ICD therapies for reasons other than ventricular tachycardia/fibrillation) ICD therapies (ATP and shocks).
Time frame: 12 months
Total VT Episodes
Total VT Episodes, detected by the ICD device, occurring in the 12 months after ablation
Time frame: 12 months
Appropriate ATP therapy rate
Total appropriate ICD ATP therapies during 12 month follow up after ablation
Time frame: 12 months
Appropriate ICD Shocks rate
Total ICD Shocks during 12 month follow up after ablation
Time frame: 12 months
Repeat catheter ablation for ischaemic ventricular tachycardia
Need for a repeat catheter ablation procedure after the study procedure and during the 12 month follow up period.
Time frame: 12 months
All cause mortality
All cause mortality
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Imperial College Healthcare NHS Trust