Quick ICD Study: Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary ?

Phase 4

Completed

• Conditions: Cardiac Arrest

• Registration Number: NCT00180362
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The purpose of this study is to evaluate the strategy of implanting an ICD with or without EPS before, during and after ICD-implantation in a randomised controlled trial, using a combined endpoint of major ICD-related adverse events as the primary outcome measure.

Detailed Description

Usually, EPS before and during ICD-implantation is performed to allow risk stratification, to test serial antiarrhythmic drugs, to find suitable ablation sites in patients with hemo-dynamically stable monomorphic VTs, to exclude supraventricular tachycardias as a cause of cardiac arrest and to help programming detection rate and enhancement criteria in the ICD. However, routine EPS preceeding ICD-implantation exposes the patient to some risk and the health care system to considerable costs. So the question has been raised, whether such testing is still necessary and costseffective, if the indiaction for ICD-implantation is clear on a clinical ground.The purpose of this study is to evaluate the strategy of implanting an ICD with or without EPS before during and after ICD-implantation in a randomised controlled trial, using a combined endpoint of major ICD-related adverse events as the primary outcome measure (see details under "Endpoints"). The results will be viewed against the extra costs and patients´ quality of life both study arms.Secondary outcomes are considered as differences in decisions between the groups and difference of events in the two groups.

Study Timeline

• Study Start: 2004-05
• Study Completion: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• structural heart disease and survived cardiac arrest or hemodynamically unstable VT (bpm > 200/min)

Exclusion Criteria

• conditions, which make a secondary cause for cardiac arrest probable or are not compatible with a single chamber ICD; co-morbidity, prior ICD PM, or EPS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Combined endpoint of major ICD-related adverse events as the primary outcome measure

Secondary Outcome Measures

Name	Time	Method
Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU

Trial Locations

Locations (1)

Allg. Krankenhaus St. Georg; 🇩🇪 Hamburg, Germany