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

NCT00170287 | Completed Phase 4

• 1 other identifier: CEN_G_CA_3
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 7

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

Keywords

Unstable Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

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

  12 Months

Secondary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

ICD Therapy plus VT-Ablation

Procedure: ICD Ablation plus VT-ablation

2

ACTIVE COMPARATOR

ICD Therapy only

Device: ICD Therapy

Interventions

ICD Ablation plus VT-ablation PROCEDURE

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

1

ICD Therapy DEVICE

ICD Therapy for the Treatment of unstable VT´s

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (7)

Skejby Skygehus

Aarhus, 8200, Denmark

Location

Herz- und Gefäßklinik GmbH

Bad Neustadt / Saale, 97616, Germany

Location

Berufsgenossenschaftliche Kliniken Bergmannsheil

Bochum, 44789, Germany

Location

Klinikum der J.W. Goethe Universität

Frankfurt, 60590, Germany

Location

Allgemeines Krankenhaus St. Georg

Hamburg, 20099, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

Klinikum der Stadt Ludwigshafen am Rhein

Ludwigshafen, 67063, Germany

Location

Related Publications (1)

• 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.

  PMID: 28292751 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl-Heinz Kuck, MD

  Allgemeines Krankenhaus St. Georg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2002
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2011
• Last Updated: July 3, 2025

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); DE (6)