At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pre-implantation planning (device), Post-implantation assessment (device)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Pre-implantation planning — device: ECGi mapping using the CE marked Amycard 01C device and a contrast enhanced CT · Post-implantation assessment — device: ECGi mapping using the CE marked Amycard 01C device and a non-contrast CT
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at people with heart failure with reduced ejection fraction (a condition where the heart pumps less blood than normal). It aims to improve the results of cardiac resynchronisation therapy (CRT), a treatment that helps the heart beat in a better rhythm, by using non-invasive heart mapping. Non-invasive means it does not require cuts or tubes inside the body.
Who can take part
- Adults aged 18 or over who give informed consent to take part
- Have had the best standard medicine treatment for heart failure for at least 3 months before screening
- Have a normal heart rhythm (sinus rhythm) at screening and meet Class I or IIa criteria from the 2013 European Society of Cardiology (ESC) CRT guidelines
- Are due to have a CRT device fitted that paces both sides of the heart (biventricular pacing)
Who may not be able to
- Have had a pacemaker, CRT device, or implanted cardioverter defibrillator (ICD) fitted before
- Have an acute illness or a flare-up of a long-term illness, as judged by the researcher
- Cannot have a CT scan (a detailed type of X-ray scan)
- Cannot have body surface heart-rhythm mapping, for example due to healing wounds on the chest, skin conditions, or allergy to the mapping electrodes or plasters
- Are pregnant or planning to become pregnant within 6 months of signing consent (women who can become pregnant need a negative pregnancy test)
- Are unable to give consent themselves, for example due to mental illness, mental disability, or lacking legal authority
What taking part involves
- • Having a CRT device placed with biventricular (both sides of the heart) pacing
- • Non-invasive heart mapping, including body surface ECG (heart rhythm) mapping using electrodes on the chest
- • A CT scan
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 85 Years
- Who
- All
- Number of participants
- 330
- Started
- 2023-12-20
- Last checked
- 2025-08
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure with reduced ejection fraction
- • NA - 330 participants
- • The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement
Who can take part?
- • Ages 18 Years to 85 Years
- • Diagnosed with heart failure with reduced ejection fraction
Where?
- • London - Bart's Hospital
- • London - King's College
- • Oxford - Oxford University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The ICONIC-M study is a multicenter randomized controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empirical lead placement. The hypothesis of the investigation is to demonstrate that CRT LV lead implantation guided by a map obtained with the Amycard 01C System and showing LV Latest Electrical Activated Site (LEAS) in combination with a CT cardiac venogram improves CRT outcome. An improved CRT outcome is defined as a ≥30% increase in LVESVi reduction compared to empiric CRT LV lead implantation. The sample size will be 136 in the Control arm and 194 in the Active arm. A total of 330 subjects. The study follows an adaptive design, in where one interim analysis at 70% enrollment will be performed. The sponsor may stop enrollment when either one of the following conditions apply: * Statistical significant difference between groups in the primary endpoint has been reached confirming a difference in reduction of the LVESVi of ≥30% in the Active arm compared to the Control arm * There is no trend or reason to believe statistical significance will be reached with a higher sample size. Statistical significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.
More detail
The study is conducted at European sites as a Post-Market Clinical Follow-Up study of a CE marked device (Amycard 01C). Its aim is to strengthen clinical evidence by assessing whether the use of this device for CRT planning improves clinical outcome in a statistically significant number of patients.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 85 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Appropriately signed and dated agreement to take part.
- ✓Age ≥18 years at time of consent.
- ✓Received optimal medical therapy for HF for at least 3 months before screening
- ✓Patient in sinus rhythm at the time of screening fulfilling Class I or IIa criteria per ESC CRT guidelines 2013 .
- ✓Patient is intended for placement of a CRT device with biventricular (BiV) pacing.
Who cannot take part
- ✗Previous heart pacemaker/CRT/ICD implantation
- ✗Acute diseases or exacerbations of chronic diseases (as per the investigator's discretion)
- ✗Contraindications to CT scanning
- ✗Contraindications to body surface ECG mapping: (ongoing wound healing on the chest (e.g. recent surgery), skin...
- ✗Pregnant, or subjects planning to become pregnant within 6 months after signing agreement to take part (a documented...
See the full criteria
Where Is This Study? (3 UK sites)
Bart's Hospital
London, United Kingdom
King's College
London, United Kingdom
Oxford University Hospital
Oxford, United Kingdom
How to Get in Touch
Matthias Egger, PhD
Sponsor contactCONTACT
Adrian Maciejewski, Dr
Sponsor contactCONTACT