Ablation for ICD Intervention Reduction in Patients With CAD

NCT00481377 | Terminated

• 1 other identifier: IK-NP-0021-42/1013/07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia; Coronary Artery Disease; Implantable Cardioverter-Defibrillator

Keywords

Ablation; Ventricular tachycardia; coronary artery disease; Implantable cardioverter defibrillator interventions

Outcome Measures

Primary Outcomes (1)

• Number of appropriate ICD interventions

Secondary Outcomes (4)

• Overall mortality

• Cardiac mortality

• Hospitalization due to arrhythmia or heart failure

• Quality of life

Interventions

ablation PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiology, Warsaw, Poland: lead

Study Sites (1)

Institute of Cardiology

Warsaw, Masovian Voivodeship, 04-628, Poland

Location

Related Publications (1)

• 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.

  PMID: 19288374 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lukasz J Szumowski, MD, PhD

  National Institute of Cardiology, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2007
• First Posted: June 1, 2007
• Study Start: May 1, 2007
• Study Completion: May 1, 2010
• Last Updated: July 21, 2008

Record last verified: 2008-07

Locations

PL (1)