Skip to main content
Clinical Trials/NCT03147027
NCT03147027
Unknown
Not Applicable

Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

Heinrich-Heine University, Duesseldorf1 site in 1 country72 target enrollmentMay 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Tachycardia
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
72
Locations
1
Primary Endpoint
occurrence of sustained VT/VF or ICD therapy
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2017
End Date
December 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Principal Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Principal Investigator

Heinrich-Heine University, Duesseldorf

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

Outcomes

Primary Outcomes

occurrence of sustained VT/VF or ICD therapy

Time Frame: 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 Outcomes

  • survival free from clinical events(time from randomization to 24 months)
  • number of appropriate ICD therapies(time from randomization to 24 months)

Study Sites (1)

Loading locations...

Similar Trials