Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease
Reason given: Principal investigator left Heart Center Leipzig.
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Trial details
- Who runs it
- Helios Health Institute GmbH
- Trial code
- NCT05203484
- Record updated
- 19 August 2022
- Original description
VT ablation is a frequently performed intervention in patients with symptomatic ventricular tachycardia, electrical storm due to monomorphic VT and appropriate ICD shocks, primarily aiming at reducing the burden of complaints, and ICD shocks. The recommendations for its use were described in the ESC guideline for ventricular arrhythmias and the prevention of sudden cardiac death. To visualize the arrhythmogenic substrate leading to ventricular tachycardia complex mapping techniques are currently used in clinical routine, including conventional Point-by-Point mapping or Multielectrode Mapping. The latter is associated with shorter Mapping and overall procedure times, while maintaining the same primary endpoint of the procedure itself. The aim of this trial is to validate, whether the reduction of mapping and procedure time is associated with a comparable long-term outcome compared with conventional Point-by-Point mapping.Read full original descriptionShow less
Effect of Multielectrode Versus Point-by-Point Mapping on Recurrence of Ventricular Tachycardia in Ischemic Heart Disease - A Prospective, Randomised Single Centre Trial
VT ablation is a frequently performed intervention in patients with symptomatic ventricular tachycardia, electrical storm due to monomorphic VT and appropriate ICD shocks, primarily aiming at reducing the burden of complaints, and ICD shocks. The recommendations for its use were described in the ESC guideline for ventricular arrhythmias and the prevention of sudden cardiac death. To visualize the arrhythmogenic substrate leading to ventricular tachycardia complex mapping techniques are currently used in clinical routine, including conventional Point-by-Point mapping or Multielectrode Mapping. The latter is associated with shorter Mapping and overall procedure times, while maintaining the same primary endpoint of the procedure itself. The aim of this trial is to validate, whether the reduction of mapping and procedure time is associated with a comparable long-term outcome compared with conventional Point-by-Point mapping.
Inclusion: Age ≥18 years; Symptomatic ventricular tachycardia with/without ICD and underlying ischemic; No need for coronary revascularisation therapy based on coronary angiography or Cardiac MRI; Class I or IIa indication for catheter ablation (according to 2015 Guidelines of the European Society of Cardiology for the management of ventricular tachycardias); Signed informed consent.
Exclusion: Previous VT ablation within the last 3 months; Patients with ventricular tachycardia and known atrial fibrillation with sufficient antiarrhythmic drug therapy regarding rhythm control of atrial fibrillation; Reversible causes of ventricular tachycardia (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection/acute myocarditis); Recent cardiovascular event including myocardial infarction, percutaneous intervention, valve or cardiac bypass surgery; Medical conditions limiting the expected survival to < 1 year; On the waiting list for heart transplant; Patients with ventricular assist device; Participation in any other randomized controlled trial; Women of childbearing potential without appropriate contraceptive measures (oral contraceptives, vaginal ring, intrauterine devices, implanon, injections, partner with vasectomy); Subjects under legal supervision or guardianship; Unable to give informed consent.