ICONIC-M: IMPROVING CRT OUTCOME WITH NON-INVASIVE CARDIAC MAPPING;A multicentre randomised controlled study to assess patient response to CRT comparing ECGI map guided left ventricular lead placement with empiric lead placement. - ICONIC-M

EP Solutions SA0 个研究点目标入组 186 人开始时间: 待定最近更新: 2024年6月18日

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•Eligible subjects must meet all of the following criteria to be included in the
•1. Appropriately signed and dated informed consent.
•2. Age >=18 years at time of consent.
•3. Considered stabilized after >=3 months of optimal medical therapy before
•4. Patient in Sinus Rhythm at the time of screening, having LBBB per ESC
•guidelines 2013.
•a. QRS duration >=120ms
•b. QS or rS in lead V1
•c. Broad (frequently notched or slurred) R waves in leads I, aVL, V5, or V6
•d. Absent Q waves in leads V5 and V6
•5. Patient is intended for placement of a CRT device with biventricular (BiV)

•Subjects that meet any of the following criteria will be excluded from the
•study: 1. Currently implanted with pacemaker or ICD with >20% RV pacing in the
•past 3 months. 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: o ongoing wound healing on the
•chest (e.g. recent surgery) o skin diseases o allergic reactions to surface
•mapping electrodes and medical band-aid 5. Pregnant, or subjects planning to
•become pregnant within 24 months after signing informed consent o 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

发起方

EP Solutions SA