Clinical trial NCT00170287: SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
Official title: Substrate Modification Study in Patients Getting an ICD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tachycardia, Ventricular
Keywords: Unstable Ventricular Tachycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-09-15
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period
timeFrame: 12 Months
Secondary outcomes:
measure: All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies)
timeFrame: 12 Months
measure: Quality of life
timeFrame: 12 Months
measure: Number of hospital readmissions due to a cardiac indication
timeFrame: 12 Months
measure: Severe clinical events
timeFrame: 12 Months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Skejby Skygehus
city: Bad Neustadt / Saale
country: Germany
facility: Herz- und Gefäßklinik GmbH
city: Bochum
country: Germany
facility: Berufsgenossenschaftliche Kliniken Bergmannsheil
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe Universität
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus St. Georg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein
Study officials:
affiliation: Allgemeines Krankenhaus St. Georg
name: Karl-Heinz Kuck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.