Ablation for ICD Intervention Reduction in Patients With CAD

Coronary Artery Disease Clinical Trial

— ABLATION 4 ICD  

Official title:

Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00481377
• Other study ID #: IK-NP-0021-42/1013/07
• Status: Terminated
• Phase: N/A
• First received: May 30, 2007
• Last updated: July 18, 2008
• Start date: May 2007
• Est. completion date: May 2010

Study information

• Verified date: July 2008
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Implantable Cardioverter-Defibrillator
• Myocardial Ischemia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• ablation

Locations

Country	Name	City	State
Poland	Institute of Cardiology	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of appropriate ICD interventions
Secondary	Overall mortality
Secondary	Cardiac mortality
Secondary	Hospitalization due to arrhythmia or heart failure
Secondary	Quality of life