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Improving CRT Outcome With Non-Invasive Cardiac Mapping

RecruitingNAAges 18 Years - 85 YearsAllEP Solutions SA
NCT05564793 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 g

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📋 Eligibility rules (as published)
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
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What it tests

  • Pre-implantation planning
  • Post-implantation assessment
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Where

11 sites
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, Netherlands
Hospital da Luz
Lisbon, Portugal
Lund University Hospital
Lund, Sweden
Karolinska University Hospital
Stockholm, Sweden

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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