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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Tachycardia, Ventricular

Treatments: Procedure: ICD Ablation plus VT-ablation; Device: ICD Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00170287

CEN_G_CA_3

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

1

Experimental group

Description:

ICD Therapy plus VT-Ablation

Treatment:

Procedure: ICD Ablation plus VT-ablation

2

Active Comparator group

Description:

ICD Therapy only

Treatment:

Device: ICD Therapy