Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ID6
Study information
Scientific title
Acronym
MAVERIC
Study hypothesis
The optimal way to manage patients who present with sustained ventricular tachycardia (VT), ventricular fibrillation (VF) or sudden cardiac death (SCD), especially in the context of comparing the traditional approach of empirical amiodarone against electrophysiology-guided interventions, which include myocardial revsacularisation, programmed ventricular stimulation and the implantable cardioverter-defibrillator (ICD).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular diseases: Heart disease
Intervention
Electrophysiology + implantable cardioverter defibrillators (ICDs) versus Amiodarone empirically
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Death
2. Arrhythmia recurrence
3. Hospitalisation
4. Drug use
5. Quality of life
6. Cost of managing patients
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1996
Overall trial end date
30/11/1999
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients who presented with sustained ventricular tachycardia (VT), ventricular fibrillation (VF) or sudden cardiac death (SCD) and survived to reach hospital within the Midlands from Feb 1997 to Jan 1999 were actively identified and entered into the study.
2. Patients who were not of child-bearing age or had a life-expectancy of <6 months from a non-arrhythmic cause were approached for entry into the trial.
Patients who were ineligible for or refused to join the trial were entered into the study's registry.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
214 (Added 19/11/09)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/11/1996
Recruitment end date
30/11/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiology
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
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
1. 1998 protocol in http://www.ncbi.nlm.nih.gov/pubmed/9764063
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15172648
Publication citations
-
Protocol
Pathmanathan RK, Lau EW, Cooper J, Newton L, Skehan JD, Garratt CJ, Griffith MJ, Potential impact of antiarrhythmic drugs versus implantable defibrillators on the management of ventricular arrhythmias: the Midlands trial of empirical amiodarone versus electrophysiologically guided intervention and cardioverter implant registry data., Heart, 1998, 80, 1, 68-70.
-
Results
Lau EW, Griffith MJ, Pathmanathan RK, Ng GA, Clune MM, Cooper J, Marshall HJ, Forsey PR, Stafford PJ, Gray RG, Skehan JD, Garratt CJ, The Midlands Trial of Empirical Amiodarone versus Electrophysiology-guided Interventions and Implantable Cardioverter-defibrillators (MAVERIC): a multi-centre prospective randomised clinical trial on the secondary prevention of sudden cardiac death., Europace, 2004, 6, 4, 257-266, doi: 10.1016/j.eupc.2004.03.009.