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

Cardiac Arrest Clinical Trial

— Quick ICD  

Official title:

Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary in Patients After Survived Cardiac Arrest? A Prospective Randomised Multi-centre Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180362
• Other study ID #: Version vom 31.3.1999
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 17, 2017
• Start date: May 2004
• Est. completion date: September 2004

Study information

• Verified date: February 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• procedure

Locations

Country	Name	City	State
Germany	Allg. Krankenhaus St. Georg	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Guidant Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined endpoint of major ICD-related adverse events as the primary outcome measure
Secondary	Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU