NCT05564793 Improving CRT Outcome With Non-Invasive Cardiac Mapping
| NCT ID | NCT05564793 |
| Status | Recruiting |
| Phase | — |
| Sponsor | EP Solutions SA |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2023-12-20 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 330 participants in total. It began in 2023-12-20 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Niraj Varma, Prof.
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT05564793 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05564793 currently recruiting?
Yes, NCT05564793 is actively recruiting participants. Contact the research team at matthias.egger@ep-solutions.ch for enrollment information.
Where is the NCT05564793 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Groningen, Netherlands, Leiden, Netherlands, Maastricht, Netherlands and 7 additional locations.
Who is sponsoring the NCT05564793 clinical trial?
NCT05564793 is sponsored by EP Solutions SA. The principal investigator is Niraj Varma, Prof. at The Cleveland Clinic. The trial plans to enroll 330 participants.
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