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Purpose of the observational study is to assess the capability of a satellite tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips to an echocardiographic core laboratory (ECL) in a real time mode without loss of quality. Additionally the prognostic efficacy of specific echo parameters in the cardiac resynchronization therapy response will be evaluated.
CORELAB-CRT is a prospective multi center Italian observational study. All echo images and clips will be transmitted by using an integrated satellite transmission system. All echo assessments performed in accordance to the centers clinical practice will be also used to investigate the prognostic efficacy of echo parameters in term of response to the cardiac resynchronization therapy (CRT). All commercially available multi-chamber CRT-D devices from any manufacturers are allowed in this observational study.
Any compatible market released right atrial, right ventricular and left ventricular lead from any manufacturer is allowed.
The echocardiography device models used to perform echo imaging for all patients participating in this analysis are GE Vivid 7, GE Vivid 9 and GE Vivid I, according to the model used in the clinical practice of the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT candidates patients | In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiographic assessment | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| ECM assessment | Agreement in the echocardiographic measurement capability (EMC) between transmitted and echocardiographic device image on the set of high quality images transmitted by STE. Each echo image will be classified as high quality image if the Mean Opinion Score (MOS) will be greater than 3 points. For each high quality echo image (MOS greater or equal 3) the EMC will be assessed to both transmitted and device echocardiographic image. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prognostic efficacy of specific echo parameters | Echocardiographic response defined as LVESV reduction ≥10% at 6 months after CRT-D implantation. | 6 months |
| Clinical composite score CCS | CCS describing patients regardless of vital status at 6 months and includes both objective and subjective measures of clinical status. |
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Inclusion Criteria:
NYHA class II, III and ambulatory IV with:
Optimized medical treatment;
Patient in sinus rhythm;
Patient is willing and able to sign an informed consent form.
Exclusion Criteria:
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In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cesare Aragno | Contact | +39 06 36004916 | caragno@kell.it |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Peraldo Neja | CORELAB Responsible | Principal Investigator |
| Cesare Aragno | Kell s.r.l. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.Camillo de Lellis Hospital | Recruiting | Rieti | 02100 | Italy |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 months |
| S.Eugenio Hospital | Recruiting | Rome | 00144 | Italy |
|
| University Hospital Campus Bio-Medico | Recruiting | Rome | 00144 | Italy |
|
| Fatebenefratelli Hospital | Recruiting | Rome | 00186 | Italy |
|