RecruitingNot ApplicableNCT05564793

Improving CRT Outcome With Non-Invasive 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


Sponsor

EP Solutions SA

Enrollment

330 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

  • Appropriately signed and dated informed consent.
  • Age ≥18 years at time of consent.
  • Received optimal medical therapy for HF for at least 3 months before screening
  • Patient in sinus rhythm at the time of screening fulfilling Class I or IIa criteria per ESC CRT guidelines 2013 .
  • Patient is intended for placement of a CRT device with biventricular (BiV) pacing.

Exclusion Criteria6

  • Previous cardiac pacemaker/CRT/ICD implantation
  • Acute diseases or exacerbations of chronic diseases (as per the investigator's discretion)
  • Contraindications to CT scanning
  • 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)
  • 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)
  • Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population

Interventions

DEVICEPre-implantation planning

ECGi mapping using the CE marked Amycard 01C device and a contrast enhanced CT

DEVICEPost-implantation assessment

ECGi mapping using the CE marked Amycard 01C device and a non-contrast CT


Locations(11)

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

Bart's Hospital

London, United Kingdom

King's College

London, United Kingdom

Oxford University Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05564793


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