Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

NCT ID: NCT03147027

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2020-12-31

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.

Conditions

Ventricular Tachycardia; Ischemic Cardiomyopathy; Reduced LVEF

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

VT ablation group

VT ablation

Intervention Type: PROCEDURE

Substrate mapping for VT will be performed with the CARTO electroanatomical system.

medication group

medication

Intervention Type: OTHER

medication to prevent sustained VT and ICD therapies

Interventions

VT ablation

Substrate mapping for VT will be performed with the CARTO electroanatomical system.

Intervention Type: PROCEDURE

medication

medication to prevent sustained VT and ICD therapies

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Klinik für Kardiologie, Pneumologie und Angiologie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Hisaki Makimoto, MD

Role: CONTACT

hisaki.makimoto@med.uni-duesseldorf.de

+492118118800

Rabea Wagstaff, MA

Role: CONTACT

rabea.wagstaff@med.uni-duesseldorf.de

+492118118800

Facility Contacts

Hisaki Makimoto, MD

Role: primary

Rabea Wagstaff, M.A.

Role: backup

Other Identifiers

15-007

Identifier Type: -

Identifier Source: org_study_id