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ISRCTN
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ISRCTN62488166
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ClinicalTrials.gov identifier
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Public title
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Substrate Mapping and Ablation in Sinus rhythm to Halt Ventricular Tachycardia
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Scientific title
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Acronym
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SMASH VT
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Serial number at source
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N/A
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Study hypothesis
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This study examines the hypothesis that “prophylactic” catheter ablation, that is ablation before Implantable Cardioverter Defibrillator (ICD) shocks, can safely decrease the possibility of subsequent ICD therapy in post-Myocardial Infarction (MI) patients receiving a defibrillator after surviving a life-threatening ventricular arrhythmic event.
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Lay summary
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Ethics approval
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Partners Institutional Review Board (protocol: 2000p-000884).
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Study design
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Randomised, non-blinded, controlled study
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Countries of recruitment
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Czech Republic, United States of America
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Disease/condition/study domain
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Ventricular tachycardia
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Participants - inclusion criteria
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Men and women who were at least 18 years old were eligible for the study if they had a history of an MI as documented by an electrocardiogram or cardiac imaging and had a planned or recent (within six months) implantation of an ICD for either:
1. Ventricular Fibrillation (VF) arrest
2. Hemodynamically-unstable Ventricular Tachycardia (VT)
3. Syncope and inducible VT during invasive electrophysiologic testing (for this group, syncope is assumed to be the qualifying spontaneous arrhythmic event)
4. Patients who had received an ICD for primary prophylaxis and then experienced a single appropriate ICD therapy
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Participants - exclusion criteria
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1. Treated with a Class I/III antiarrhythmic drug
2. The substrate for the ventricular arrhythmia was thought not to be due to the myocardial infarction
3. Active ongoing cardiac ischemia was felt to be the cause of the ventricular arrhythmia;
4. Incessant or multiple VT episodes necessitating some form of treatment – drugs or ablation
5. Unable to give informed consent
6. If the patient had experienced a stroke within 30 days
7. Contraindication to anticoagulation
8. Any medical/non-medical condition likely to prevent completion of the trial
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Anticipated start date
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01/08/2000
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Anticipated end date
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01/10/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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128
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Interventions
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Randomisation between:
1. Implantable defibrillator
2. Implantable defibrillator plus catheter ablation of ventricular tachycardia
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Primary outcome measure(s)
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Defibrillator events (shocks and anti-tachycardia therapy)
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Secondary outcome measure(s)
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1. Mortality
2. ICD shocks
3. Left ventricular ejection fraction
4. Heart failure status
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Sources of funding
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Investigator funded and initiated trial
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Trial website
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Publications
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Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18160685
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Contact name
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Dr
Mark
Josephson
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Address
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Chief, Cardiovascular Division
Beth Israel Deaconess Medical Center
185 Pilgrim Road, Baker 4
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City/town
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Boston, Massachusetts
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Zip/Postcode
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02215
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Country
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United States of America
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Tel
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+1 617 632 7393
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Fax
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+1 617 632 7620
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Email
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shavilan@bidmc.harvard.edu
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Sponsor
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Beth Israel - Deaconess Hospital (USA)
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Address
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Cardiology Division
Department of Internal Medicine
185 Pilgrim Road, Baker 4
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City/town
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Boston, Massachusetts
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Zip/Postcode
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02215
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Country
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United States of America
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Tel
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+1 617 632 7457
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Fax
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+1 617 632 7620
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Email
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vreddy@partners.org
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Date applied
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19/09/2006
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Last edited
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06/08/2008
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Date ISRCTN assigned
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25/09/2006
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