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Clinical trialNCT05564793RecruitingInterventional

Improving CRT Outcome With Non-Invasive Cardiac Mapping

SponsorEP Solutions SAEnrollment330Heart Failure With Reduced Ejection Fraction
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Netherlands
  • Amsterdam University Medical Center

    Amsterdam, Netherlands

    Not, yet, recruiting
  • Groningen University Medical Center

    Groningen, Netherlands

    Not, yet, recruiting
  • Leids Universitair Medical Center

    Leiden, Netherlands

    Not, yet, recruiting
  • Maastricht University Hospital

    Maastricht, Netherlands

    Recruiting
  • Utrecht University Medical Center

    Utrecht, Netherlands

    Not, yet, recruiting
Portugal
  • Hospital Da Luz

    Lisbon, Portugal

    Not, yet, recruiting
Sweden
  • Lund University Hospital

    Lund, Sweden

    Not, yet, recruiting
  • Karolinska University Hospital

    Stockholm, Sweden

    Not, yet, recruiting
United Kingdom
  • Bart'S Hospital

    London, United Kingdom

    Not, yet, recruiting
  • King'S College

    London, United Kingdom

    Not, yet, recruiting
  • Oxford University Hospital

    Oxford, United Kingdom

    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
20 Dec 2023
Primary completion
30 Sept 2027
Completion
31 Dec 2027
Last update posted
7 Aug 2025
Registered enrollment
330
Registry id
NCT05564793

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.