Ablation for ICD Intervention Reduction in Patients With CAD (ABLATION 4 ICD)

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: NCT00481377
Recruitment Status : Terminated
First Posted : June 1, 2007
Last Update Posted : July 21, 2008
Information provided by:
Institute of Cardiology, Warsaw, Poland

May 30, 2007
June 1, 2007
July 21, 2008
May 2007
Not Provided
Number of appropriate ICD interventions
Same as current
Complete list of historical versions of study NCT00481377 on Archive Site
  • Overall mortality
  • Cardiac mortality
  • Hospitalization due to arrhythmia or heart failure
  • Quality of life
Same as current
Not Provided
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Ablation for ICD Intervention Reduction in Patients With CAD
Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial
The aim of this study is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The patients will be randomized into ablation arm and conventional treatment. Number of appropriate ICD interventions is the primary endpoint of this study. All patients will have control follow-up visits every 3 months. The follow-up will be based on ICD memory.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Ventricular Tachycardia
  • Coronary Artery Disease
  • Implantable Cardioverter-Defibrillator
Procedure: ablation
Not Provided
Szumowski Ł, Przybylski A, Maciag A, Derejko P, Bodalski R, Zakrzewska J, Orczykowski M, Szufladowicz E, Szwed H, Walczak F. Outcomes of a single centre registry of patients with ischaemic heart disease, qualified for an RF ablation of ventricular arrhythmia after ICD intervention. Kardiol Pol. 2009 Feb;67(2):123-7; discussion 128-9. English, Polish.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2010
Not Provided

Inclusion Criteria:

  • Coronary Artery Disease
  • ICD implanted
  • Appropriate ICD intervention during the 3 months prior to enrollment
  • Coronary angiography during the 6 months prior to enrollment
  • Possible revascularization
  • Age over 18 years
  • Signed informed consent

Exclusion Criteria:

  • Age less then 18 years
  • Pregnancy
  • Active participation in other trial
  • Heart failure (NYHA IV)
  • Contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access.
  • Monomorphic, incessant, ventricular tachycardia
  • Revascularization or other cardio-surgical procedure scheduled in the next 6 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Institute of Cardiology, Warsaw, Poland
Not Provided
Principal Investigator: Lukasz J Szumowski, MD, PhD Institute of Cardiology, Warsaw, Poland
Institute of Cardiology, Warsaw, Poland
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP