Ablation for ICD Intervention Reduction in Patients With CAD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ventricular Tachycardia Coronary Artery Disease Implantable Cardioverter-Defibrillator

Keywords

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Ablation Ventricular tachycardia coronary artery disease Implantable cardioverter defibrillator interventions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Lukasz J Szumowski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology, Warsaw, Poland

Locations

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Institute of Cardiology

Warsaw, Masovian Voivodeship, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED

PMID: 19288374 (View on PubMed)

Other Identifiers

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IK-NP-0021-42/1013/07

Identifier Type: -

Identifier Source: org_study_id