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MRI scans could help decide who needs a heart defibrillator

NCT ID NCT01918215

Disease control Sponsor: Flinders University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tested whether using a heart MRI to find scar tissue can help decide which people with mild-to-moderate heart failure should get a defibrillator (ICD) to prevent sudden cardiac death. About 449 adults with a weakened heart pump (ejection fraction 36-50%) and scar tissue on MRI were randomly assigned to receive an ICD or a small heart monitor. The goal was to see if the ICD group had fewer dangerous heart rhythms or sudden death over three years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

453 people

The number who actually took part.

Started

Jul 2015

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age equal or greater than 18 years * Patients with coronary artery disease (CAD) or dilated cardiomyopathy (DCM) of the idiopathic, chronic post myocarditis or familial type. * Left ventricular systolic impairment as defined by left ventricular ejection fraction 36-50% by any current standard technique (echocardiogram, multiple gated acquisition scan (MUGA), angiography or CMR taken in the last six months. If a LGE CMR has been taken within 2 months this scan can be used for inclusion * Able and willing to comply with all pre-, post- and follow-up testing, and requirements * On maximum tolerated doses of ACE inhibitors (or Angiotensin and Receptor Blockers if intolerant of ACE) and Beta Blockers Exclusion Criteria: 1. History of cardiac arrest or spontaneous or inducible sustained ventricular tachycardia or ventricular fibrillation unless within 48 hours of an acute MI 2. Cardiomyopathy related to sarcoidosis 3. Standard Cardiac Magnetic Resonance imaging contraindications (e.g. severe claustrophobia) 4. Currently implanted permanent pacemaker and/or pacemaker/ICD lead 5. Clinical indication for ICD or Pacemaker or cardiac resynchronisation therapy. 6. CMR LVEF ≤35% or\>50% 7. Severe renal insufficiency (eGFR\< 30mls/min/1.73m2) 8. Recent Myocardial Infarction (MI) (\<40 days) or cardiac revascularization (\<90 days) 9. New York Heart Association HF functional class IV at baseline 10. Conditions associated with life expectancy \<1 year 11. Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception

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Conditions

The condition(s) this trial relates to.

coronary artery disorder dilated cardiomyopathy heart failure intrinsic cardiomyopathy left ventricular failure myocardial ischemia systolic heart failure Ventricular Dysfunction, Left

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure Left ventricular systolic dysfunction

Contacts and locations

Locations

  • Belfast Health and Social Care Trust

    Belfast, BT12 6NT, United Kingdom

  • Coburg Hospital

    Coburg, 96450, Germany

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Glenfield General Hospital

    Leicester, LE39QP, United Kingdom

  • Golden Jubilee National Hospital

    Clydebank, G814DY, United Kingdom

  • John Hunter Hospital

    New Lambton, New South Wales, 2305, Australia

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112, Australia

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102, Australia

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78052, Germany

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065, Australia

  • The Alfred

    Melbourne, Victoria, 3004, Australia

  • The Bristol Heart Institute

    Bristol, BS2 8HW, United Kingdom

  • University Hospital Wurzburg

    Würzburg, 97080, Germany

  • University Hospital of South Manchester NHS Foundation Trust

    Manchester, M23 9LT, United Kingdom

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