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

NCT ID: NCT00170287

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2011-08-31

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.

Conditions

Tachycardia, Ventricular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

ICD Therapy plus VT-Ablation

Group Type: EXPERIMENTAL

ICD Ablation plus VT-ablation

Intervention Type: PROCEDURE

ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification

2

ICD Therapy only

Group Type: ACTIVE_COMPARATOR

ICD Therapy

Intervention Type: DEVICE

ICD Therapy for the Treatment of unstable VT´s

Interventions

ICD Ablation plus VT-ablation

ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification

Intervention Type: PROCEDURE

ICD Therapy

ICD Therapy for the Treatment of unstable VT´s

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl-Heinz Kuck, MD

Role: PRINCIPAL_INVESTIGATOR

Allgemeines Krankenhaus St. Georg

Locations

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

Countries

Denmark; Germany

References

Kuck KH, Tilz RR, Deneke T, Hoffmann BA, Ventura R, Hansen PS, Zarse M, Hohnloser SH, Kautzner J, Willems S; SMS Investigators. Impact of Substrate Modification by Catheter Ablation on Implantable Cardioverter-Defibrillator Interventions in Patients With Unstable Ventricular Arrhythmias and Coronary Artery Disease: Results From the Multicenter Randomized Controlled SMS (Substrate Modification Study). Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004422. doi: 10.1161/CIRCEP.116.004422.

Reference Type: DERIVED

PMID: 28292751 (View on PubMed)

Other Identifiers

CEN_G_CA_3

Identifier Type: -

Identifier Source: org_study_id