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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: procedure

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.

• Study Type: Interventional
• Enrollment: 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, D-20099
    • Allg. Krankenhaus St. Georg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Combined endpoint of major ICD-related adverse events as the primary outcome measure

Secondary Outcome Measures

Outcome Measure
Costs, quality of life, differences in decision making, cardiovascular events , 18 months FU

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: Guidant Corporation
• Investigators: Principal Investigator: K. H Kuck, MD, Allg. Krankenhaus St. Georg

Study record dates

Study Major Dates

• Study Start: May 1, 2004
• Study Completion: September 1, 2004

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: Version vom 31.3.1999