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Substrate Modification Study in Patients Getting an ICD
The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation and/or antiarrhythmic medication in the event of recurrences causing frequent ICD interventions. The primary purpose of this randomized study is the assessment of recurrences of unstable VT in patients who undergo ICD implantation plus substrate ablation after the initial episode compared to patients who only undergo ICD implantation. Thus the primary purpose is an improvement in the quality of life. A decrease in mortality is not a primary purpose of this study.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Skejby Skygehus
Aarhus, Denmark
Herz- und Gefäßklinik GmbH
Bad Neustadt / Saale, Germany
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, Germany
Klinikum der J.W. Goethe Universität
Frankfurt, Germany
Allgemeines Krankenhaus St. Georg
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, Germany
Start Date
May 1, 2002
Primary Completion Date
April 1, 2010
Completion Date
August 1, 2011
Last Updated
July 3, 2025
116
ACTUAL participants
ICD Ablation plus VT-ablation
PROCEDURE
ICD Therapy
DEVICE
Lead Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
NCT00147277
NCT01085435
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05676398