Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (nsVT)

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 Overview

• Status: Unknown
• Conditions: Ventricular Tachycardia; Ischemic Cardiomyopathy; Reduced LVEF
• Intervention / Treatment: Procedure: VT ablation; Other: medication

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

• Study Contact: Name: Hisaki Makimoto, MD; Phone Number: +492118118800; Email: hisaki.makimoto@med.uni-duesseldorf.de
• Study Contact Backup: Name: Rabea Wagstaff, MA; Phone Number: +492118118800; Email: rabea.wagstaff@med.uni-duesseldorf.de

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine
    • Contact: Hisaki Makimoto, MD
    • Contact: Rabea Wagstaff, M.A.
    • Principal Investigator: Hisaki Makimoto, MD
    • Sub-Investigator: Alexander Fürnkranz, MD
    • Sub-Investigator: Patrick Müller, MD
    • Sub-Investigator: Lukas Clasen, MD
    • Sub-Investigator: Jan Schmidt, MD
    • Sub-Investigator: Muhammed Kurt, MD
    • Sub-Investigator: Christoph Brinkmeyer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with nonsustained VT and ischemic cardiomyopathy and reduced LVEF

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VT ablation group	Procedure: VT ablation; Substrate mapping for VT will be performed with the CARTO electroanatomical system.
medication group	Other: medication; medication to prevent sustained VT and ICD therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of sustained VT/VF or ICD therapy	occurrence of sustained VT/VF or ICD therapy including ATP and shock	time from randomization to occurrence of any sustained VT/VF within 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 from randomization to 24 months
number of appropriate ICD therapies	number of appropriate ICD therapies (ATP or shock)	time from randomization to 24 months

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: ischemic cardiomyopathy; prophylactic ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ischemia; Tachycardia; Tachycardia, Ventricular; Cardiomyopathies
• Other Study ID Numbers: 15-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No