Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Cardiac Resynchronization Therapy, Left Bundle Branch Block
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.
Detailed description
The study is conducted at European sites as a Post-Market Clinical Follow-Up study of a CE marked device (Amycard 01C). Its aim is to strengthen clinical evidence by assessing whether the use of this device for CRT planning improves clinical outcome in a statistically significant number of patients.
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
Sponsors
QserveCRO
EP Solutions SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
A multicenter randomized controlled study to assess patient response to cardiac resynchronization therapy comparing ECGI map guided left ventricular lead placement with empirical lead placement.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of left ventricular end-systolic volume index (LVESVi) | 6 months post CRT implantation | Reduction versus baseline of LVESVi as measured by transthoracic echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successfully placed LV leads | 6 months post CRT implantation | Rate of successfully placed LV leads in the control and active arms |
| Correctly predicted distance between latest activation site and LV lead | 6 months post implantation | Rate of correctly predicted distance between the latest electrical activation site, as identified with Amycard 01C, and the LV lead, as identified on CT |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Composite Score | 6 months post CRT implantation | Clinical composite score consisting of Quality of life questionnaire, mortality rate and heart failure hospitalization rate |
| Shift of Latest Electrical Activation Site | 6 months post CRT implantation | Degree of shift of the latest electrical activation site, as identified using the Amycard 01C device, between baseline and the six-months follow-up |
| ECGi acquisition procedural failure rate | 6 months post CRT implantation | Rate of unsuccessful ECGi mapping procedures using the Amycard 01C device |
| Subgroup analysis | 6 months post CRT implantation | Subgroup analysis including stratification based on various conditions or habits (ischemia, diabetes, smoking, pulmonary disease, impaired right ventricular function, etc) |
Countries
Netherlands, Portugal, Sweden, United Kingdom
Contacts
Primary ContactMatthias Egger, PhD
Backup ContactAdrian Maciejewski, Dr
Outcome results
None listed