Substrate Mapping and Ablation in Sinus rhythm to Halt Ventricular Tachycardia

ISRCTN ISRCTN62488166
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

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

Study information

Study designRandomised, non-blinded, controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study acronymSMASH VT
Study objectivesThis 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) studiedVentricular tachycardia
InterventionRandomisation between:
1. Implantable defibrillator
2. Implantable defibrillator plus catheter ablation of ventricular tachycardia
Intervention typeOther
Primary outcome measureDefibrillator events (shocks and anti-tachycardia therapy)
Secondary outcome measures1. Mortality
2. ICD shocks
3. Left ventricular ejection fraction
4. Heart failure status
Overall study start date01/08/2000
Completion date01/10/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants128
Key inclusion criteriaMen 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 criteria1. 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 enrolment01/08/2000
Date of final enrolment01/10/2003

Locations

Countries of recruitment

  • Czech Republic
  • United States of America

Study participating centre

Chief, Cardiovascular Division
Boston, Massachusetts
02215
United States of America

Sponsor information

Beth Israel - Deaconess Hospital (USA)
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
Email vreddy@partners.org
ROR logo "ROR" https://ror.org/04drvxt59

Funders

Funder type

Other

Investigator funded and initiated trial

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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