Ventricular Tachycardia, Ischemic Cardiomyopathy, Reduced LVEF
Conditions
Keywords
ischemic cardiomyopathy, prophylactic ablation
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.
Interventions
PROCEDUREVT ablation
Substrate mapping for VT will be performed with the CARTO electroanatomical system.
OTHERmedication
medication to prevent sustained VT and ICD therapies
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of sustained VT/VF or ICD therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| survival free from clinical events | time from randomization to 24 months | 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) |
| number of appropriate ICD therapies | time from randomization to 24 months | number of appropriate ICD therapies (ATP or shock) |
Countries
Germany
Contacts
Primary ContactHisaki Makimoto, MD
Backup ContactRabea Wagstaff, MA
Outcome results
None listed