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OpenTrials
Completed

NCT Number: NCT00180362

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Allg. Krankenhaus St. Georg

Hamburg, D-20099, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

procedure

Device

Primary outcomes

  1. Combined endpoint of major ICD-related adverse events as the primary outcome measure

Secondary outcomes

  1. Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • Guidant Corporation

Registry information

Official study 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.

Acronym: Quick ICD

Important dates

Study start
2004
Study completion
2004
First posted
Sep 16, 2005
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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