Heart Failure With Reduced Ejection FractionICONIC-MNCT05564793
Improving CRT Outcome With Non-Invasive Cardiac Mapping
A study testing Pre-implantation planning and Post-implantation assessment in people with Heart Failure With Reduced Ejection Fraction, run by EP Solutions SA at 11 sites in 4 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Pre-implantation planning and Post-implantation assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 20 Dec 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous cardiac 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 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)
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Adrian Maciejewski, Dr contact
11 sites in 4 countries
Netherlands5 sites, 5 recruiting
- Not yet recruiting
Amsterdam University Medical Center
Amsterdam
Cornelius Allaart, Dr
- Not yet recruiting
Groningen University Medical Center
Groningen
Alexander Maas, Dr
- Not yet recruiting
Leids Universitair Medical Center
Leiden
Anastasia Egorova, Dr
- Recruiting
Maastricht University Hospital
Maastricht
Twan van Stipdonk, Dr
- Not yet recruiting
Utrecht University Medical Center
Utrecht
Mathias Meine, Dr
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Bart's Hospital
London
Pier Lambiase, Dr
- Not yet recruiting
King's College
London
Aldo Rinaldi, Dr
- Not yet recruiting
Oxford University Hospital
Oxford
Tim Betts, Dr
Sweden2 sites, 2 recruiting
- Not yet recruiting
Lund University Hospital
Lund
Rasmus Borgquist, Dr
- Not yet recruiting
Karolinska University Hospital
Stockholm
Fredrik Gadler, Dr
Portugal1 site, 1 recruiting
- Not yet recruiting
Hospital da Luz
Lisbon
Ana Leonor Parreira, Dra
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Being tested
- Pre-implantation planning, Post-implantation assessment
- Keywords
- Cardiac Resynchronization Therapy, Left Bundle Branch Block
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-implantation planningDevice
Also called ECGI mapping
ECGi mapping using the CE marked Amycard 01C device and a contrast enhanced CT
Post-implantation assessmentDevice
Also called ECGI mapping
ECGi mapping using the CE marked Amycard 01C device and a non-contrast CT
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Device: Post-implantation assessment |
| Active | Experimental | 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. Receives: Device: Pre-implantation planning; Device: Post-implantation assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of left ventricular end-systolic volume index (LVESVi)
Reduction versus baseline of LVESVi as measured by transthoracic echocardiography
Measured: 6 months post CRT implantation
Secondary outcomes (2)
Successfully placed LV leads
Rate of successfully placed LV leads in the control and active arms
Measured: 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
Measured: 6 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start20 Dec 2023
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter randomized controlled study to assess patient response to cardiac resynchronization therapy comparing ECGI map guided left ventricular lead placement with empirical lead placement.
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EP Solutions SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QserveCRO
- Responsible party
- Sponsor
- Investigators
- Niraj Varma, Prof., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564793
- Sponsor's protocol ID
- DCR013-22
- Acronym
- ICONIC-M
- Status last verified
- Aug 2025
- First submitted
- 29 Sep 2022
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05564793
- Acronym / sponsor ID
- ICONIC-M / DCR013-22
- Keywords
- Cardiac Resynchronization Therapy, Left Bundle Branch Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- EP Solutions SAIndustry (pharma, biotech, devices)
- Collaborators
- QserveCRO
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multicenter randomized controlled study to assess patient response to cardiac resynchronization therapy comparing ECGI map guided left ventricular lead placement with empirical lead placement.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Post-implantation assessmentThe 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. |
| Active | Experimental | Device: Pre-implantation planning, Device: Post-implantation assessmentA 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous cardiac 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 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-implantation planningAlso: ECGI mappingECGi mapping using the CE marked Amycard 01C device and a contrast enhanced CT | Device | Active |
| Post-implantation assessmentAlso: ECGI mappingECGi mapping using the CE marked Amycard 01C device and a non-contrast CT | Device | Active, Control |
Primary outcome
Reduction of left ventricular end-systolic volume index (LVESVi)
Time frame: 6 months post CRT implantation
Reduction versus baseline of LVESVi as measured by transthoracic echocardiography
2 secondary outcomes
Successfully placed LV leads
Time frame: 6 months post CRT implantation
Correctly predicted distance between latest activation site and LV lead
Time frame: 6 months post implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adrian Maciejewski, Dr contact
Niraj Varma, Prof. principal investigator
The Cleveland Clinic
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-implantation planning and Post-implantation assessment in people with Heart Failure With Reduced Ejection Fraction, run by EP Solutions SA at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands, United Kingdom, Sweden, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Egger, PhD (+41 78 659 22 75, matthias.egger@ep-solutions.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of left ventricular end-systolic volume index (LVESVi) (time frame: 6 months post CRT implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.