Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

Heinrich-Heine University, Duesseldorf72 enrolled

Overview

Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter ablation in patients with nonsustained VT has been not yet clarified. The incidence of appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can result in the prognostic improvement.To suppress ventricular arrhythmias aside from antiarrhythmic agents, catheter ablation has been developed prominently in this decade along with the technological improvement such as irrigated ablation catheters, three-dimensional mapping systems, multi-polar catheters, and image integration system with CT and MRI. The rationale of this trial is to study the efficacy of the eradication of arrhythmogenic substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of the occurrence of sustained VT/VF and ICD therapies.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ventricular Tachycardia Ischemic Cardiomyopathy Reduced LVEF

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * left ventricular ejection fraction (TTE or MRI) ≤40% * diagnosed ischemic heart disease * nonsustained monomorphic VT with more than 5 beats in the record of the implantable cardioverter-defibrillator or in any means of electrocardiogram (ECG) including ECG monitor and holter monitoring * ICD implantation with primary preventive indication Exclusion Criteria: * ICD implantation within 2 months * previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock * no written informed consent

Outcomes

Primary Outcomes

occurrence of sustained VT/VF or ICD therapy

occurrence of sustained VT/VF or ICD therapy including ATP and shock

Time frame: time from randomization to occurrence of any sustained VT/VF within 24 months

Secondary Outcomes

survival free from clinical events

survival free from clinical events (death, syncope, hospital admission due to cardiac problems, and VT storm, defined as more than three VT episodes in 24 hours)

Time frame: time from randomization to 24 months

number of appropriate ICD therapies

number of appropriate ICD therapies (ATP or shock)