Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VT ablation group |
| ||
| medication group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT ablation | Procedure | Substrate mapping for VT will be performed with the CARTO electroanatomical system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| number of appropriate ICD therapies |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
patients with nonsustained VT and ischemic cardiomyopathy and reduced LVEF
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hisaki Makimoto, MD | Contact | +492118118800 | hisaki.makimoto@med.uni-duesseldorf.de | |
| Rabea Wagstaff, MA | Contact | +492118118800 | rabea.wagstaff@med.uni-duesseldorf.de |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Pulmonary Disease and Vascular Medicine | Recruiting | Düsseldorf | 40225 | Germany |
Not provided
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
| medication | Other | medication to prevent sustained VT and ICD therapies |
|
number of appropriate ICD therapies (ATP or shock) |
| time from randomization to 24 months |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |