Improving heart failure treatment with advanced cardiac mapping
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
NA · EP Solutions SA · NCT05564793
This study is testing if using advanced heart mapping to guide a specific heart treatment can help people with heart failure feel better compared to the usual methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | EP Solutions SA (industry) |
| Locations | 11 sites (Amsterdam and 10 other locations) |
| Trial ID | NCT05564793 on ClinicalTrials.gov |
What this trial studies
The ICONIC-M study is a multicenter randomized controlled trial designed to evaluate the effectiveness of cardiac resynchronization therapy (CRT) guided by advanced non-invasive cardiac mapping compared to traditional lead placement methods. The study utilizes the Amycard 01C System to identify the optimal left ventricular lead placement based on the latest electrical activation site. By comparing outcomes in a total of 330 participants, the study aims to demonstrate a significant improvement in heart function as measured by left ventricular end-systolic volume index (LVESVi). An interim analysis will be conducted to assess the efficacy of the intervention during the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with heart failure who are in sinus rhythm and are suitable for CRT device implantation.
Not a fit: Patients with previous cardiac device implants or those with contraindications to CT scanning or body surface ECG mapping may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart function and quality of life for patients with heart failure.
How similar studies have performed: Previous studies have shown promising results with similar mapping techniques, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam and 10 other locations
- 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)
Study contacts
- Principal investigator: Niraj Varma, Prof. — The Cleveland Clinic
- Study coordinator: Matthias Egger, PhD
- Email: matthias.egger@ep-solutions.ch
- Phone: +41 78 659 22 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Reduced Ejection Fraction, Cardiac Resynchronization Therapy, Left Bundle Branch Block