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| Name | Class |
|---|---|
| QserveCRO | UNKNOWN |
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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 significance (primary endpoint) is reached at interim (70%) or at total (100%) of enrollment with a significance value P lower than 0.025.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | The CRT device is implanted according to clinical practice, without pre-implantation planning. The outcome of the procedure is assessed via echography as per clinical practice. In addition to clinical practice, the subjects are required to fill in a quality-of-life questionnaire and are subject to an ECG mapping procedure with the Amycard 01C device, including non-contrast CT, to assess the distance between left ventricular lead placement and the latest electrical activation site in the absence of planning information. |
|
| Active | Experimental | A pre-implantation ECG mapping with the Amycard 01C device, including CT, is performed prior to the CRT device implantation. The resulting target area for the left ventricular lead placement is communicated to the implanting physician, who will attempt to reach a point close to the target, using the available venous access. At six-month follow-up, response to the therapy is assessed using echocardiography, and a second ECG mapping with Amycard 01C is performed, to assess the distance between actual implantation site and target in the presence of pre-implantation planning information. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-implantation planning | Device | ECGi mapping using the CE marked Amycard 01C device and a contrast enhanced CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of left ventricular end-systolic volume index (LVESVi) | Reduction versus baseline of LVESVi as measured by transthoracic echocardiography | 6 months post CRT implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Successfully placed LV leads | Rate of successfully placed LV leads in the control and active arms | 6 months post CRT implantation |
| Correctly predicted distance between latest activation site and LV lead |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Composite Score | Clinical composite score consisting of Quality of life questionnaire, mortality rate and heart failure hospitalization rate | 6 months post CRT implantation |
| ECGi acquisition procedural failure rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthias Egger, PhD | Contact | +41 78 659 22 75 | matthias.egger@ep-solutions.ch | |
| Adrian Maciejewski, Dr | Contact | adrian.maciejewski@ep-solutions.ch |
| Name | Affiliation | Role |
|---|---|---|
| Niraj Varma, Prof. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam University Medical Center | Not yet recruiting | Amsterdam | Netherlands |
| ID | Term |
|---|---|
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| Post-implantation assessment | Device | ECGi mapping using the CE marked Amycard 01C device and a non-contrast CT |
|
|
Rate of correctly predicted distance between the latest electrical activation site, as identified with Amycard 01C, and the LV lead, as identified on CT
| 6 months post implantation |
Rate of unsuccessful ECGi mapping procedures using the Amycard 01C device
| 6 months post CRT implantation |
| Subgroup analysis | Subgroup analysis including stratification based on various conditions or habits (ischemia, diabetes, smoking, pulmonary disease, impaired right ventricular function, etc) | 6 months post CRT implantation |
| Shift of Latest Electrical Activation Site | Degree of shift of the latest electrical activation site, as identified using the Amycard 01C device, between baseline and the six-months follow-up | 6 months post CRT implantation |
| Groningen University Medical Center | Not yet recruiting | Groningen | Netherlands |
|
| Leids Universitair Medical Center | Not yet recruiting | Leiden | Netherlands |
|
| Maastricht University Hospital | Recruiting | Maastricht | Netherlands |
|
| Utrecht University Medical Center | Not yet recruiting | Utrecht | Netherlands |
|
| Hospital da Luz | Not yet recruiting | Lisbon | Portugal |
|
| Lund University Hospital | Not yet recruiting | Lund | Sweden |
|
| Karolinska University Hospital | Not yet recruiting | Stockholm | Sweden |
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| Bart's Hospital | Not yet recruiting | London | United Kingdom |
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| King's College | Not yet recruiting | London | United Kingdom |
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| Oxford University Hospital | Not yet recruiting | Oxford | United Kingdom |
|
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |