Testing heart mapping to guide pacemaker lead placement in heart failure
Tests whether heart mapping guides cardiac resynchronization device placement in adults with heart failure.
Plain-language title generated from the registry record
Registry title: Improving CRT Outcome With Non-Invasive Cardiac Mapping
Key facts
- Where
- London and Oxford, United KingdomSee the 3 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure with reduced ejection fraction who are about to get a CRT device with biventricular pacing. It tests whether a heart map helps place the left ventricular lead.
- Age
- 18 to 85 years
- Sex
- All sexes
- Disease stage
- Heart failure in sinus rhythm that meets Class I or IIa criteria of the 2013 ESC CRT guidelines. A CRT device with biventricular (BiV) pacing is planned.
- Earlier treatment
- Must have had optimal medical therapy for heart failure for at least 3 months before screening. Must not have had a pacemaker, CRT or ICD implanted before.
Main reasons for not taking part
- Previous pacemaker, CRT or ICD implant
- Acute disease or flare of a long-term disease, as the investigator decides
- Cannot have a CT scan
- Cannot have body surface ECG mapping (for example a healing chest wound, skin disease, or allergy to the electrodes or band-aid)
- Pregnant, or planning pregnancy within 6 months after signing consent
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05564793, who can take part
Where in United Kingdom
- Bart's HospitalLondon, United KingdomNot yet recruiting
- King's CollegeLondon, United KingdomNot yet recruiting
- Oxford University HospitalOxford, United KingdomNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EP Solutions SA
- Trial code
- NCT05564793
- Record updated
- 7 August 2025
- Original description
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.Read full original descriptionShow less
ICONIC-M: Improving CRT Outcome With Non-Invasive Cardiac Mapping. A Multicenter Randomized Controlled Study To Assess Patient Response to CRT Comparing ECGI Map Guided Left Ventricular Lead Placement With Empirical Lead Placement
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.
Inclusion: Appropriately signed and dated informed consent; 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.
Exclusion: Previous cardiac pacemaker/CRT/ICD implantation; Acute diseases or exacerbations of chronic diseases (as per the investigator's discretion); Contraindications to body surface ECG mapping: (ongoing wound healing on the chest (e.g. recent surgery), skin diseases, allergic reactions to surface mapping electrodes and medical band-aid); Pregnant, or subjects planning to become pregnant within 6 months after signing informed consent (a documented negative pregnancy test (serum or blood) is required for women of childbearing potential); Contraindications to CT scanning; Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.