SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)

Study Overview
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Brief Summary
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The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent ICD interventions. The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation. Thus the primary purpose is an improvement in the quality of life. A decrease in mortality is not a primary purpose of this study.

Official Title
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Substrate Modification Study in Patients Getting an ICD

Conditions
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Tachycardia, Ventricular

Intervention / Treatment
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* Procedure: ICD Ablation plus VT-ablation
* Device: ICD Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary artery disease documented by coronary angiography. For the purpose of this study, coronary artery disease will be defined as the presence of a 50% or more diameter stenosis of the left main or of a 75% or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure. Left ventricular ejection fraction < 40% as estimated by echocardiography or contrast ventriculography within the previous 30 days. Clinical unstable VT without reversible factors (acute ischemia or antiarrhythmic medications as defined below). Unstable VT can have one of the following clinical presentations: Hypotensive VT without major neurologic dysfunction; Syncope; or Cardiac arrest. Exclusion Criteria: Age < 18 years or > 80 years Protruding left ventricular (LV) thrombus on pre-ablation echocardiogram Acute myocardial infarction within the preceding 2 months Class IV New York Heart Association (NYHA) heart failure Valvular heart disease or mechanical heart valve precluding access to the left ventricle Unstable angina Cardiac surgery within the past 2 months Serum creatinine > 220 mmol/L (2.5 mg/dL) Thrombocytopenia or coagulopathy Contraindication to heparin Pregnancy Acute illness or active systemic infection Other disease process likely to limit survival to less than 12 months Significant medical problem that, in the opinion of the principal investigator, would preclude enrollment into the study Participation in another investigational study Unwillingness to participate or lack of availability for follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ICD Therapy plus VT-Ablation | Procedure: ICD Ablation plus VT-ablation<br>* ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification<br>|
| Active Comparator: 2<br>ICD Therapy only | Device: ICD Therapy<br>* ICD Therapy for the Treatment of unstable VT´s<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies) |  | 12 Months | 
| Quality of life |  | 12 Months | 
| Number of hospital readmissions due to a cardiac indication |  | 12 Months | 
| Severe clinical events |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unstable Ventricular Tachycardia