MAVERIC: Midlands trial of amiodarone vs electrophysiology-guided interventions and cardio-defibrillator in ventricular arrhythmias.

ISRCTN	ISRCTN14274472
DOI	https://doi.org/10.1186/ISRCTN14274472
Secondary identifying numbers	ID6

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Michael Griffith
Scientific

Department of Cardiology
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom

Phone	+44 (0)121 627 2043

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	MAVERIC
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular diseases: Heart disease
Intervention	Electrophysiology + implantable cardioverter defibrillators (ICDs) versus Amiodarone empirically
Intervention type	Other
Primary outcome measure	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 study start date	01/11/1996
Completion date	30/11/1999

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	214 (Added 19/11/09)
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/11/1996
Date of final enrolment	30/11/1999

Department of Cardiology

Birmingham
B15 2TH
United Kingdom

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/07/1998		Yes	No
Results article	results	01/07/2004		Yes	No