Condition category
Circulatory System
Date applied
19/09/2006
Date assigned
25/09/2006
Last edited
06/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18160685

Publication citations

  1. 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.

Additional files

Editorial Notes