Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/12/2009
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 Michael Griffith

ORCID ID

Contact details

Department of Cardiology
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
+44 (0)121 627 2043

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes