Substrate Mapping and Ablation in Sinus rhythm to Halt Ventricular Tachycardia

ISRCTN	ISRCTN62488166
DOI	https://doi.org/10.1186/ISRCTN62488166
Protocol serial number	N/A
Sponsor	Beth Israel - Deaconess Hospital (USA)
Funder	Investigator funded and initiated trial

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mark Josephson
Scientific

Chief, Cardiovascular Division
Beth Israel Deaconess Medical Center
185 Pilgrim Road, Baker 4
Boston, Massachusetts
02215
United States of America

Phone	+1 617 632 7393
Email	shavilan@bidmc.harvard.edu

Primary study design	Interventional
Study design	Randomised, non-blinded, controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SMASH VT
Study objectives	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(s)	Partners Institutional Review Board (protocol: 2000p-000884).
Health condition(s) or problem(s) studied	Ventricular tachycardia
Intervention	Randomisation between: 1. Implantable defibrillator 2. Implantable defibrillator plus catheter ablation of ventricular tachycardia
Intervention type	Other
Primary outcome measure(s)	Defibrillator events (shocks and anti-tachycardia therapy)
Key secondary outcome measure(s)	1. Mortality 2. ICD shocks 3. Left ventricular ejection fraction 4. Heart failure status
Completion date	01/10/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	128
Key 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
Key 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
Date of first enrolment	01/08/2000
Date of final enrolment	01/10/2003

Chief, Cardiovascular Division

Boston, Massachusetts
02215
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	27/12/2007		Yes	No