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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
  Purpose

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 Intervention
Ventricular Tachycardia
Coronary Artery Disease
Implantable Cardioverter-Defibrillator
 Procedure: ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Number of appropriate ICD interventions

Secondary Outcome Measures:
  • Overall mortality
  • Cardiac mortality
  • Hospitalization due to arrhythmia or heart failure
  • Quality of life

Estimated Enrollment: 200
Study Start Date: May 2007
Estimated Study Completion Date: May 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481377

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

No publications provided by Institute of Cardiology, Warsaw, Poland

Additional 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
Study First Received: May 30, 2007
Last Updated: July 18, 2008
Health Authority: Poland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 21, 2013