SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)

Tachycardia, Ventricular Clinical Trial

— SMS  

Official title:

Substrate Modification Study in Patients Getting an ICD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170287
• Other study ID #: CEN_G_CA_3
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: September 5, 2017
• Start date: May 2002
• Est. completion date: August 2011

Study information

• Verified date: September 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular

Intervention

Procedure:
• ICD Ablation plus VT-ablation
ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification

Device:
• ICD Therapy
ICD Therapy for the Treatment of unstable VT´s

Locations

Country	Name	City	State
Denmark	Skejby Skygehus	Aarhus
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Countries where clinical trial is conducted

Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first documented recurrence of any sustained VT/ventricular fibrillation (VF) during the follow-up period		12 Months
Secondary	All appropriate ICD therapies (number of shocks, number of antitachycardia pacing therapies)		12 Months
Secondary	Quality of life		12 Months
Secondary	Number of hospital readmissions due to a cardiac indication		12 Months
Secondary	Severe clinical events		12 Months