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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Ventricular Tachycardia; Implantable Cardioverter-Defibrillator
• Intervention / Treatment: Procedure: ablation

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 04-628
      • Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of appropriate ICD interventions

Secondary Outcome Measures

Outcome Measure
Quality of life
Cardiac mortality
Overall mortality
Hospitalization due to arrhythmia or heart failure

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland
• Investigators: Principal Investigator: Lukasz J Szumowski, MD, PhD, Institute of Cardiology, Warsaw, Poland

Publications and helpful links

General Publications

• Szumowski L, 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: May 30, 2007
• First Submitted That Met QC Criteria: May 31, 2007
• First Posted (Estimate): June 1, 2007

Study Record Updates

• Last Update Posted (Estimate): July 21, 2008
• Last Update Submitted That Met QC Criteria: July 18, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: coronary artery disease; Ablation; Ventricular tachycardia; Implantable cardioverter defibrillator interventions
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: IK-NP-0021-42/1013/07