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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00180362
Acronym
Quick ICD
Enrollment
200
Registered
2005-09-16
Start date
2004-05-31
Completion date
2004-09-30
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

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.

Interventions

DEVICEprocedure

Sponsors

Guidant Corporation
CollaboratorINDUSTRY
Boston Scientific Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Combined endpoint of major ICD-related adverse events as the primary outcome measure

Secondary

MeasureTime frame
Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026