SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD) - Full Text View

Sponsors and Collaborators:	Medtronic Bakken Research Center Medtronic
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00170287

Purpose

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.

Condition	Intervention	Phase
Tachycardia, Ventricular	Procedure: ICD Ablation plus VT-ablation Device: ICD Therapy	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Substrate Modification Study in Patients Getting an ICD

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Number of hospital readmissions due to a cardiac indication [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Severe clinical events [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	116
Study Start Date:	May 2002
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ICD Therapy plus VT-Ablation	Procedure: ICD Ablation plus VT-ablation ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification
2: Active Comparator ICD Therapy only	Device: ICD Therapy ICD Therapy for the Treatment of unstable VT´s

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Coronary artery disease documented by coronary angiography. For the purpose of this study, coronary artery disease will be defined as the presence of a 50% or more diameter stenosis of the left main or of a 75% or more diameter stenosis of the left anterior descending, circumflex or right coronary arteries, or the history of a surgical or percutaneous revascularization procedure.
Left ventricular ejection fraction < 40% as estimated by echocardiography or contrast ventriculography within the previous 30 days.
Clinical unstable VT without reversible factors (acute ischemia or antiarrhythmic medications as defined below). Unstable VT can have one of the following clinical presentations:
- Hypotensive VT without major neurologic dysfunction;
- Syncope; or
- Cardiac arrest.

Exclusion Criteria:

Age < 18 years or > 80 years
Protruding left ventricular (LV) thrombus on pre-ablation echocardiogram
Acute myocardial infarction within the preceding 2 months
Class IV New York Heart Association (NYHA) heart failure
Valvular heart disease or mechanical heart valve precluding access to the left ventricle
Unstable angina
Cardiac surgery within the past 2 months
Serum creatinine > 220 mmol/L (2.5 mg/dL)
Thrombocytopenia or coagulopathy
Contraindication to heparin
Pregnancy
Acute illness or active systemic infection
Other disease process likely to limit survival to less than 12 months
Significant medical problem that, in the opinion of the principal investigator, would preclude enrollment into the study
Participation in another investigational study
Unwillingness to participate or lack of availability for follow-up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170287

Contacts

Contact: Karl-Heinz Kuck, MD	040/2890-2305	kuck@uke.uni-hamburg.de
Contact: M. Antz, MD

Locations

Denmark
Skejby Skygehus	Recruiting
Aarhus, Denmark, 8200
Contact: Peter Stehen Hansen, MD
Germany
Allgemeines Krankenhaus St. Georg	Recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, MD 040 28903854 kuck@uke.uni-hamburg.de
Contact: M. Antz, MD
Universitätsklinikum Hamburg-Eppendorf	Recruiting
Hamburg, Germany, 20251
Contact: Stefan Willems, MD
Contact: Rudolfo Ventura, MD
Berufsgenossenschaftliche Kliniken Bergmannsheil	Recruiting
Bochum, Germany, 44789
Contact: Thomas Lawo, MD 0234 3020
Contact: Thomas Deneke, MD 0234 3020
Klinikum der Stadt Ludwigshafen am Rhein	Recruiting
Ludwigshafen, Germany, 67063
Contact: Karl-heinz Seidl, MD 06215032002 seiddlk@klilu.de
Herz- und Gefäßklinik GmbH	Recruiting
Bad Neustadt / Saale, Germany, 97616
Contact: Burghard Schumacher, MD 09771 662602 schumacher@kardiologie-bad-neustadt.de
Klinikum der J.W. Goethe Universität	Recruiting
Frankfurt, Germany, 60590
Contact: Stefan Hohnloser, MD 06963017017 hohnloser@em.uni-frankfurt.de

Sponsors and Collaborators

Medtronic Bakken Research Center

Medtronic

Investigators

Principal Investigator:

Karl-Heinz Kuck, MD

Allgemeines Krankenhaus St. Georg

More Information

Responsible Party:	Asklepios Kliniken Hamburg GmbH ( Professor Dr. med. K--H. Kuck )
Study ID Numbers:	CEN_G_CA_3
Study First Received:	September 9, 2005
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00170287
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:

Unstable Ventricular Tachycardia

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009