Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia. (RIPPLE-VT)
|ClinicalTrials.gov Identifier: NCT03997201|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : October 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia Ischemic Heart Disease||Procedure: Ripple Mapping guided ischaemic VT ablation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective clinical trial|
|Masking:||None (Open Label)|
|Official Title:||Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia: A Multi-centre Prospective Clinical Trial.|
|Actual Study Start Date :||April 18, 2019|
|Estimated Primary Completion Date :||April 18, 2020|
|Estimated Study Completion Date :||April 18, 2021|
Ripple Mapping guided ischaemic VT ablation
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.
- Any appropriate ICD therapy [ Time Frame: 12 months ]ICD therapy (ATP and shocks) for sustained ventricular tachycardia or ventricular fibrillation as documented by the patients device. Device interrogations occur 3 monthly.
- Achievement of the ablation procedure protocol end-point [ Time Frame: Procedure ]Abolition of abnormal electrical activity within ischaemic ventricular scar by Ripple Mapping guided ablation
- Total ICD therapy rate [ Time Frame: 12 months ]Toral appropriate and inappropriate (defined as ICD therapies for reasons other than ventricular tachycardia/fibrillation) ICD therapies (ATP and shocks).
- All cause mortality [ Time Frame: 12 months ]All cause mortality
- Repeat catheter ablation for ischaemic ventricular tachycardia [ Time Frame: 12 months ]Need for a repeat catheter ablation procedure after the study procedure and during the 12 month follow up period.
- All cause hospitalisation [ Time Frame: 12 months ]All cause hospitalisation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997201
|Contact: George Katritsis, MBChB||020 3313 firstname.lastname@example.org|
|Contact: Prapa Kanagaratnam, MD, PhD||020 3313 email@example.com|
|Principal Investigator:||Prapa Kanagaratnam||Imperial College Healthcare NHS Trust|