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

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ClinicalTrials.gov Identifier: NCT00481377
Recruitment Status : Terminated
First Posted : June 1, 2007
Last Update Posted : July 21, 2008
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Ventricular Tachycardia Coronary Artery Disease Implantable Cardioverter-Defibrillator Procedure: ablation

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial
Study Start Date : May 2007
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Number of appropriate ICD interventions

Secondary Outcome Measures :
  1. Overall mortality
  2. Cardiac mortality
  3. Hospitalization due to arrhythmia or heart failure
  4. Quality of life

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00481377

Institute of Cardiology
Warsaw, Mazowieckie, Poland, 04-628
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Principal Investigator: Lukasz J Szumowski, MD, PhD Institute of Cardiology, Warsaw, Poland
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00481377     History of Changes
Other Study ID Numbers: IK-NP-0021-42/1013/07
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: July 21, 2008
Last Verified: July 2008

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Ventricular tachycardia
coronary artery disease
Implantable cardioverter defibrillator interventions

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Arrhythmias, Cardiac
Pathologic Processes