Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

• Conditions: Ventricular Tachycardia; Ischemic Cardiomyopathy; Reduced LVEF
• Interventions: Procedure: VT ablation; Other: medication

• Registration Number: NCT03147027
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-25
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VT ablation group	VT ablation	-
medication group	medication	-

Primary Outcome Measures

Name	Time	Method
occurrence of sustained VT/VF or ICD therapy	time from randomization to occurrence of any sustained VT/VF within 24 months	occurrence of sustained VT/VF or ICD therapy including ATP and shock

Secondary Outcome Measures

Name	Time	Method
survival free from clinical events	time from randomization to 24 months	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)
number of appropriate ICD therapies	time from randomization to 24 months	number of appropriate ICD therapies (ATP or shock)

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Düsseldorf, Germany