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

Primary Purpose

Ventricular Tachycardia, Coronary Artery Disease, Implantable Cardioverter-Defibrillator

Status
Terminated
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
ablation
Sponsored by
National Institute of Cardiology, Warsaw, Poland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ablation, Ventricular tachycardia, coronary artery disease, Implantable cardioverter defibrillator interventions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Cardiology

Outcomes

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

Full Information

First Posted
May 30, 2007
Last Updated
July 18, 2008
Sponsor
National Institute of Cardiology, Warsaw, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT00481377
Brief Title
Ablation for ICD Intervention Reduction in Patients With CAD
Acronym
ABLATION 4 ICD
Official Title
Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Terminated
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Coronary Artery Disease, Implantable Cardioverter-Defibrillator
Keywords
Ablation, Ventricular tachycardia, coronary artery disease, Implantable cardioverter defibrillator interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
ablation
Primary Outcome Measure Information:
Title
Number of appropriate ICD interventions
Secondary Outcome Measure Information:
Title
Overall mortality
Title
Cardiac mortality
Title
Hospitalization due to arrhythmia or heart failure
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz J Szumowski, MD, PhD
Organizational Affiliation
National Institute of Cardiology, Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Cardiology
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
04-628
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19288374
Citation
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.
Results Reference
derived

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Ablation for ICD Intervention Reduction in Patients With CAD

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