Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180362
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2005-09-12
Brief Title:
Quick ICD Study Is Extensive Electrophysiological Testing Before During and After ICD-Implantation Still Necessary
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Quick ICD
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 groundThe 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 armsSecondary outcomes are considered as differences in decisions between the groups and difference of events in the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None