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

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180362
First received: September 12, 2005
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest
Device: procedure
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Guidant Corporation:

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

Estimated Enrollment: 200
Study Start Date: May 2004
Estimated Study Completion Date: September 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180362

Locations
Germany
Allg. Krankenhaus St. Georg
Hamburg, Germany, D-20099
Sponsors and Collaborators
Guidant Corporation
Investigators
Principal Investigator: K. H Kuck, MD Allg. Krankenhaus St. Georg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180362     History of Changes
Other Study ID Numbers: Version vom 31.3.1999
Study First Received: September 12, 2005
Last Updated: February 3, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014