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NCT Number: NCT05564793

Improving CRT Outcome With Non-Invasive Cardiac Mapping

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction Arrhythmias, Cardiac Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam University Medical Center, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Pre-implantation planning

Device

ECGi mapping using the CE marked Amycard 01C device and a contrast enhanced CT

Other names: ECGI mapping

Post-implantation assessment

Device

ECGi mapping using the CE marked Amycard 01C device and a non-contrast CT

Other names: ECGI mapping

Primary outcomes

  1. 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

Secondary outcomes

  1. Successfully placed LV leads

    Time frame: 6 months post CRT implantation

    Rate of successfully placed LV leads in the control and active arms

  2. Correctly predicted distance between latest activation site and LV lead

    Time frame: 6 months post implantation

    Rate of correctly predicted distance between the latest electrical activation site, as identified with Amycard 01C, and the LV lead, as identified on CT

Other outcomes

  1. Clinical Composite Score

    Time frame: 6 months post CRT implantation

    Clinical composite score consisting of Quality of life questionnaire, mortality rate and heart failure hospitalization rate

  2. ECGi acquisition procedural failure rate

    Time frame: 6 months post CRT implantation

    Rate of unsuccessful ECGi mapping procedures using the Amycard 01C device

  3. Subgroup analysis

    Time frame: 6 months post CRT implantation

    Subgroup analysis including stratification based on various conditions or habits (ischemia, diabetes, smoking, pulmonary disease, impaired right ventricular function, etc)

  4. Shift of Latest Electrical Activation Site

    Time frame: 6 months post CRT implantation

    Degree of shift of the latest electrical activation site, as identified using the Amycard 01C device, between baseline and the six-months follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Adrian Maciejewski, Dr

CONTACT

[email protected]

Matthias Egger, PhD

CONTACT

[email protected]

+41 78 659 22 75

Sponsors and collaborators

Lead sponsor

EP Solutions SA

Industry

Collaborators

  • QserveCRO

Registry information

Official study 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

Acronym: ICONIC-M

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 4, 2022
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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