Contact information
Type
Scientific
Primary contact
Dr Mark Josephson
ORCID ID
Contact details
Chief
Cardiovascular Division
Beth Israel Deaconess Medical Center
185 Pilgrim Road
Baker 4
Boston
Massachusetts
02215
United States of America
+1 617 632 7393
shavilan@bidmc.harvard.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SMASH VT
Study hypothesis
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.
Ethics approval
Partners Institutional Review Board (protocol: 2000p-000884).
Study design
Randomised, non-blinded, controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Ventricular tachycardia
Intervention
Randomisation between:
1. Implantable defibrillator
2. Implantable defibrillator plus catheter ablation of ventricular tachycardia
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Defibrillator events (shocks and anti-tachycardia therapy)
Secondary outcome measures
1. Mortality
2. ICD shocks
3. Left ventricular ejection fraction
4. Heart failure status
Overall trial start date
01/08/2000
Overall trial end date
01/10/2003
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128
Participant exclusion criteria
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
Recruitment start date
01/08/2000
Recruitment end date
01/10/2003
Locations
Countries of recruitment
Czech Republic, United States of America
Trial participating centre
Chief, Cardiovascular Division
Boston, Massachusetts
02215
United States of America
Sponsor information
Organisation
Beth Israel - Deaconess Hospital (USA)
Sponsor details
Cardiology Division
Department of Internal Medicine
185 Pilgrim Road
Baker 4
Boston
Massachusetts
02215
United States of America
+1 617 632 7457
vreddy@partners.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator funded and initiated trial
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
-
Results
Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME, Prophylactic catheter ablation for the prevention of defibrillator therapy., N. Engl. J. Med., 2007, 357, 26, 2657-2665, doi: 10.1056/NEJMoa065457.