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Improving CRT Outcome With Non-Invasive Cardiac Mapping

NCT05564793 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-08-07

No results posted yet for this study

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.

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.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DEVICE

Pre-implantation planning

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

DEVICE

Post-implantation assessment

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

Sponsors & Collaborators

  • QserveCRO

    collaborator UNKNOWN

  • EP Solutions SA

    lead INDUSTRY

Principal Investigators

  • Niraj Varma, Prof. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Netherlands
  • Portugal
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05564793 on ClinicalTrials.gov