Improving CRT Outcome With Non-Invasive Cardiac Mapping

Heart Failure With Reduced Ejection Fraction Clinical Trial

— ICONIC-M  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564793
• Other study ID #: DCR013-22
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: EP Solutions SA
• Contact: Matthias Egger, PhD
• Phone: +41 78 659 22 75
• Email: matthias.egger[@]ep-solutions.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: June 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 criteria per ESC CRT guidelines 2013 .

5. Patient is intended for placement of a CRT device with biventricular (BiV) pacing.

Exclusion Criteria:

1. Previous cardiac pacemaker/CRT/ICD implantation

2. Acute diseases or exacerbations of chronic diseases (as per the investigator's discretion)

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 electrodes and medical band-aid)

5. 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)

6. Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Device:
• Pre-implantation planning
ECGi mapping using the CE marked Amycard 01C device and a contrast enhanced CT
• Post-implantation assessment
ECGi mapping using the CE marked Amycard 01C device and a non-contrast CT

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center	Amsterdam
Netherlands	Groningen University Medical Center	Groningen
Netherlands	Leids Universitair Medical Center	Leiden
Netherlands	Maastricht University Hospital	Maastricht
Netherlands	Utrecht University Medical Center	Utrecht
Portugal	Hospital da Luz	Lisbon
Sweden	Lund University Hospital	Lund
Sweden	Karolinska University Hospital	Stockholm
United Kingdom	Bart's Hospital	London
United Kingdom	King's College	London
United Kingdom	Oxford University Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
EP Solutions SA

Countries where clinical trial is conducted

Netherlands,  Portugal,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Composite Score	Clinical composite score consisting of Quality of life questionnaire, mortality rate and heart failure hospitalization rate	6 months post CRT implantation
Other	ECGi acquisition procedural failure rate	Rate of unsuccessful ECGi mapping procedures using the Amycard 01C device	6 months post CRT implantation
Other	Subgroup analysis	Subgroup analysis including stratification based on various conditions or habits (ischemia, diabetes, smoking, pulmonary disease, impaired right ventricular function, etc)	6 months post CRT implantation
Other	Shift of Latest Electrical Activation Site	Degree of shift of the latest electrical activation site, as identified using the Amycard 01C device, between baseline and the six-months follow-up	6 months post CRT implantation
Primary	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	Successfully placed LV leads	Rate of successfully placed LV leads in the control and active arms	6 months post CRT implantation
Secondary	Correctly predicted distance between latest activation site and LV lead	Rate of correctly predicted distance between the latest electrical activation site, as identified with Amycard 01C, and the LV lead, as identified on CT	6 months post implantation