Improving heart failure treatment with advanced cardiac mapping

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Maastricht University Hospital
  Maastricht, Netherlands Recruiting
• 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
• Utrecht University Medical Center
  Utrecht, Netherlands Not yet recruiting
• Hospital da Luz
  Lisbon, Portugal 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.