Quick ICD Study: Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary ? (Quick ICD)
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
procedure
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest
Eligibility Criteria
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
Sites / Locations
- Allg. Krankenhaus St. Georg
Outcomes
Primary Outcome Measures
Combined endpoint of major ICD-related adverse events as the primary outcome measure
Secondary Outcome Measures
Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU
Full Information
NCT ID
NCT00180362
First Posted
September 12, 2005
Last Updated
February 17, 2017
Sponsor
Boston Scientific Corporation
Collaborators
Guidant Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00180362
Brief Title
Quick ICD Study: Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary ?
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Scientific Corporation
Collaborators
Guidant Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
procedure
Primary Outcome Measure Information:
Title
Combined endpoint of major ICD-related adverse events as the primary outcome measure
Secondary Outcome Measure Information:
Title
Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. H Kuck, MD
Organizational Affiliation
Allg. Krankenhaus St. Georg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allg. Krankenhaus St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Quick ICD Study: Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary ?
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