Improving CRT Outcome With Non-Invasive Cardiac Mapping

NCT05564793 | Recruiting DMC

• 1 other identifier: DCR013-22
• Study Type: interventional
• Target: 330
• Locations: 4 countries
• Sites: 11

Brief 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

Keywords

Cardiac Resynchronization Therapy; Left Bundle Branch Block

Outcome Measures

Primary Outcomes (1)

• Reduction of left ventricular end-systolic volume index (LVESVi)

  Reduction versus baseline of LVESVi as measured by transthoracic echocardiography

  6 months post CRT implantation

Secondary Outcomes (2)

• Successfully placed LV leads

  6 months post CRT implantation

• Correctly predicted distance between latest activation site and LV lead

  6 months post implantation

Other Outcomes (4)

• Clinical Composite Score

  6 months post CRT implantation

• ECGi acquisition procedural failure rate

  6 months post CRT implantation

• Subgroup analysis

  6 months post CRT implantation

Study Arms (2)

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.

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.

Device: Pre-implantation planning; Device: Post-implantation assessment

Interventions

Pre-implantation planning DEVICE

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

Also known as: ECGI mapping

Active

Post-implantation assessment DEVICE

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

Also known as: ECGI mapping

Active; Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EP Solutions SA: lead
• QserveCRO: collaborator

Study Sites (11)

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

Hospital da Luz

Lisbon, Portugal

NOT YET RECRUITING

Lund University Hospital

Lund, Sweden

NOT YET RECRUITING

Karolinska University Hospital

Stockholm, Sweden

NOT YET RECRUITING

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

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Niraj Varma, Prof.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias Egger, PhD

CONTACT

+41 78 659 22 75; matthias.egger@ep-solutions.ch

Adrian Maciejewski, Dr

CONTACT

adrian.maciejewski@ep-solutions.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 4, 2022
• Study Start: December 20, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

PT (1); NL (5); SE (2); GB (3)