Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

Ventricular Tachycardia Clinical Trial

— nsVT  

Official title:

Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03147027
• Other study ID #: 15-007
• Status: Recruiting
• Start date: May 2, 2017
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Hisaki Makimoto, MD
• Phone: +492118118800
• Email: hisaki.makimoto[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy
• Reduced LVEF
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• VT ablation
Substrate mapping for VT will be performed with the CARTO electroanatomical system.

Other:
• medication
medication to prevent sustained VT and ICD therapies

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	number of appropriate ICD therapies	number of appropriate ICD therapies (ATP or shock)	time from randomization to 24 months