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

Phase 4

Completed

• Conditions: Tachycardia, Ventricular

• Registration Number: NCT00170287
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2010-04
• Study Completion: 2011-08-01
• Status Verified: 2017-09
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period	12 Months

Secondary Outcome Measures

Name	Time	Method
All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies)	12 Months
Severe clinical events	12 Months
Number of hospital readmissions due to a cardiac indication	12 Months
Quality of life	12 Months

Trial Locations

Locations (7)

Skejby Skygehus; 🇩🇰 Aarhus, Denmark

Herz- und Gefäßklinik GmbH; 🇩🇪 Bad Neustadt / Saale, Germany

Berufsgenossenschaftliche Kliniken Bergmannsheil; 🇩🇪 Bochum, Germany

Klinikum der J.W. Goethe Universität; 🇩🇪 Frankfurt, Germany

Allgemeines Krankenhaus St. Georg; 🇩🇪 Hamburg, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Klinikum der Stadt Ludwigshafen am Rhein; 🇩🇪 Ludwigshafen, Germany