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Completed

NCT Number: NCT00170287

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Skejby Skygehus, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICD Ablation plus VT-ablation

Procedure

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

ICD Therapy

Device

ICD Therapy for the Treatment of unstable VT´s

Primary outcomes

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

    Time frame: 12 Months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Official study title

Substrate Modification Study in Patients Getting an ICD

Acronym: SMS

Important dates

Study start
2002
Primary completion
2010
Study completion
2011
First posted
Sep 15, 2005
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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