An interventional study of Pre-implantation planning and Post-implantation assessment in Heart Failure With Reduced Ejection Fraction, sponsored by EP Solutions SA. Recruiting at 11 sites in 4 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by EP Solutions SA · Not applicable, Interventional, and Diagnostic
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 significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.
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.
94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.
This study's planned enrollment of 330 is above the median of 60 across 59 interventional studies indexed under Bundle-Branch Block.
Browse Bundle-Branch Block studies →This is the only study on the registry with EP Solutions SA as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The CRT device is implanted according to clinical practice, without pre-implantation planning. The outcome of the procedure is assessed via echography as per clinical practice. In addition to clinical practice, the subjects are required to fill in a quality-of-life questionnaire and are subject to an ECG mapping procedure with the Amycard 01C device, including non-contrast CT, to assess the distance between left ventricular lead placement and the latest electrical activation site in the absence of planning information.
Device: Post-implantation assessment
A pre-implantation ECG mapping with the Amycard 01C device, including CT, is performed prior to the CRT device implantation. The resulting target area for the left ventricular lead placement is communicated to the implanting physician, who will attempt to reach a point close to the target, using the available venous access. At six-month follow-up, response to the therapy is assessed using echocardiography, and a second ECG mapping with Amycard 01C is performed, to assess the distance between actual implantation site and target in the presence of pre-implantation planning information.
Device: Pre-implantation planning · Device: Post-implantation assessment
ECGi mapping using the CE marked Amycard 01C device and a contrast enhanced CT
Also known as: ECGI mapping
ECGi mapping using the CE marked Amycard 01C device and a non-contrast CT
Also known as: ECGI mapping
Reduction of left ventricular end-systolic volume index (LVESVi)
Reduction versus baseline of LVESVi as measured by transthoracic echocardiography
Time frame: 6 months post CRT implantation
Successfully placed LV leads
Rate of successfully placed LV leads in the control and active arms
Time frame: 6 months post CRT implantation
Correctly predicted distance between latest activation site and LV lead
Rate of correctly predicted distance between the latest electrical activation site, as identified with Amycard 01C, and the LV lead, as identified on CT
Time frame: 6 months post implantation
Clinical Composite Score
Clinical composite score consisting of Quality of life questionnaire, mortality rate and heart failure hospitalization rate
Time frame: 6 months post CRT implantation
ECGi acquisition procedural failure rate
Rate of unsuccessful ECGi mapping procedures using the Amycard 01C device
Time frame: 6 months post CRT implantation
Subgroup analysis
Subgroup analysis including stratification based on various conditions or habits (ischemia, diabetes, smoking, pulmonary disease, impaired right ventricular function, etc)
Time frame: 6 months post CRT implantation
Shift of Latest Electrical Activation Site
Degree of shift of the latest electrical activation site, as identified using the Amycard 01C device, between baseline and the six-months follow-up
Time frame: 6 months post CRT implantation
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