Improving CRT Outcome With Non-Invasive Cardiac Mapping

Last updated: May 6, 2024
Sponsor: EP Solutions SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

Post-implantation assessment

Pre-implantation planning

Clinical Study ID

NCT05564793
DCR013-22
  • Ages 18-85
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Appropriately signed and dated informed consent.
  2. Age ≥18 years at time of consent.
  3. Received optimal medical therapy for HF for at least 3 months before screening
  4. Patient in sinus rhythm at the time of screening fulfilling Class I or IIa criteriaper ESC CRT guidelines 2013 .
  5. Patient is intended for placement of a CRT device with biventricular (BiV) pacing.

Exclusion

Exclusion Criteria:

  1. Previous cardiac pacemaker/CRT/ICD implantation
  2. Acute diseases or exacerbations of chronic diseases (as per the investigator'sdiscretion)
  3. Contraindications to CT scanning
  4. Contraindications to body surface ECG mapping: (ongoing wound healing on the chest (e.g. recent surgery), skin diseases, allergic reactions to surface mapping electrodesand medical band-aid)
  5. Pregnant, or subjects planning to become pregnant within 6 months after signinginformed consent (a documented negative pregnancy test (serum or blood) is requiredfor women of childbearing potential)
  6. Incapacitated individuals, defined as persons who are mentally ill, mentallyhandicapped, or individuals without legal authority, are excluded from the studypopulation

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Post-implantation assessment
Phase:
Study Start date:
December 20, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Hospital Sant'Orsola

    Bologna,
    Italy

    Site Not Available

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Groningen University Medical Center

    Groningen,
    Netherlands

    Site Not Available

  • Leids Universitair Medical Center

    Leiden,
    Netherlands

    Site Not Available

  • Maastricht University Hospital

    Maastricht,
    Netherlands

    Active - Recruiting

  • Utrecht University Medical Center

    Utrecht,
    Netherlands

    Site Not Available

  • Hospital da Luz

    Lisbon,
    Portugal

    Site Not Available

  • Sahlgrenska University

    Göteborg,
    Sweden

    Site Not Available

  • Lund University Hospital

    Lund,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • Bart's Hospital

    London,
    United Kingdom

    Site Not Available

  • King's College

    London,
    United Kingdom

    Site Not Available

  • Royal Brompton Hospital

    London,
    United Kingdom

    Site Not Available

  • Oxford University Hospital

    Oxford,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.