Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

NCT03147027 | Unknown

• 1 other identifier: 15-007
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

ischemic cardiomyopathy; prophylactic ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• survival free from clinical events

  time from randomization to 24 months

• number of appropriate ICD therapies

  time from randomization to 24 months

Study Arms (2)

VT ablation group

Procedure: VT ablation

medication group

Other: medication

Interventions

VT ablation PROCEDURE

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

VT ablation group

medication OTHER

medication to prevent sustained VT and ICD therapies

medication group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with nonsustained VT and ischemic cardiomyopathy and reduced LVEF

You may qualify if:

• 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

You may not qualify if:

• ICD implantation within 2 months
• previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock
• no written informed consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Hisaki Makimoto, MD

CONTACT

+492118118800; hisaki.makimoto@med.uni-duesseldorf.de

Rabea Wagstaff, MA

CONTACT

+492118118800; rabea.wagstaff@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 10, 2017
• Study Start: May 2, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

DE (1)