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

Plain Language Summary

Simplified for easier understanding

This trial is investigating whether a non-invasive body surface mapping technique — which uses electrodes placed on the chest to create a detailed electrical map of the heart — can help doctors better program a cardiac resynchronization therapy (CRT) device before implantation, leading to better outcomes for heart failure patients. **You may be eligible if...** - You are 18 or older - You have heart failure and have been on optimal medical treatment for at least 3 months - You are in normal heart rhythm (sinus rhythm) - Your doctor has recommended CRT device implantation based on established guidelines **You may NOT be eligible if...** - You have already had a pacemaker, CRT device, or implantable defibrillator - You have an active or worsening illness - You cannot have a CT scan - You have a skin condition, recent chest wound, or allergy to ECG electrode patches that prevents body surface mapping - You are pregnant or planning to become pregnant within 6 months - You lack legal capacity to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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