Substrate Mapping and Ablation in Sinus rhythm to Halt Ventricular Tachycardia
ISRCTN | ISRCTN62488166 |
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DOI | https://doi.org/10.1186/ISRCTN62488166 |
Secondary identifying numbers | N/A |
- Submission date
- 19/09/2006
- Registration date
- 25/09/2006
- Last edited
- 06/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mark Josephson
Scientific
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 |
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shavilan@bidmc.harvard.edu |
Study information
Study design | Randomised, non-blinded, controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
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 | 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 study start date | 01/08/2000 |
Completion date | 01/10/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Czech Republic
- United States of America
Study participating centre
Chief, Cardiovascular Division
Boston, Massachusetts
02215
United States of America
02215
United States of America
Sponsor information
Beth Israel - Deaconess Hospital (USA)
Hospital/treatment centre
Hospital/treatment centre
Cardiology Division
Department of Internal Medicine
185 Pilgrim Road, Baker 4
Boston, Massachusetts
02215
United States of America
Phone | +1 617 632 7457 |
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vreddy@partners.org | |
https://ror.org/04drvxt59 |
Funders
Funder type
Other
Investigator funded and initiated trial
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results: | 27/12/2007 | Yes | No |