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Trial record 95 of 661 for:    SMS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170287
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 6, 2017
Information provided by (Responsible Party):
Medtronic Bakken Research Center

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.

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Procedure: ICD Ablation plus VT-ablation Device: ICD Therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Substrate Modification Study in Patients Getting an ICD
Study Start Date : May 2002
Actual Primary Completion Date : April 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
ICD Therapy plus VT-Ablation
Procedure: ICD Ablation plus VT-ablation
ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification

Active Comparator: 2
ICD Therapy only
Device: ICD Therapy
ICD Therapy for the Treatment of unstable VT´s

Primary Outcome Measures :
  1. Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies) [ Time Frame: 12 Months ]
  2. Quality of life [ Time Frame: 12 Months ]
  3. Number of hospital readmissions due to a cardiac indication [ Time Frame: 12 Months ]
  4. Severe clinical events [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170287

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Skejby Skygehus
Aarhus, Denmark, 8200
Herz- und Gefäßklinik GmbH
Bad Neustadt / Saale, Germany, 97616
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany, 44789
Klinikum der J.W. Goethe Universität
Frankfurt, Germany, 60590
Allgemeines Krankenhaus St. Georg
Hamburg, Germany, 20099
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20251
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, Germany, 67063
Sponsors and Collaborators
Medtronic Bakken Research Center
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Principal Investigator: Karl-Heinz Kuck, MD Allgemeines Krankenhaus St. Georg

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medtronic Bakken Research Center Identifier: NCT00170287     History of Changes
Other Study ID Numbers: CEN_G_CA_3
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Medtronic Bakken Research Center:
Unstable Ventricular Tachycardia
Additional relevant MeSH terms:
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Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes