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

This study has been terminated.
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT00481377
First received: May 30, 2007
Last updated: July 18, 2008
Last verified: July 2008
History of Changes

May 30, 2007
July 18, 2008
May 2007
Not Provided
Number of appropriate ICD interventions
Same as current
Complete list of historical versions of study NCT00481377 on ClinicalTrials.gov Archive Site
  • Overall mortality
  • Cardiac mortality
  • Hospitalization due to arrhythmia or heart failure
  • Quality of life
Same as current
Not Provided
Not Provided
 
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ventricular Tachycardia
  • Coronary Artery Disease
  • Implantable Cardioverter-Defibrillator
Procedure: ablation
Not Provided
Szumowski ?, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00481377
IK-NP-0021-42/1013/07
No
Not Provided
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