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| Name | Class |
|---|---|
| General Electrics France | UNKNOWN |
Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in patients with refractory symptomatic chronic heart failure with reduced ejection fraction (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically ameliorated. They are called the "non responders". Patient selection seams to be one of the key to improve the efficiency of CRT. This protocol try to assess positive predictive factors to CRT by a multimodal approach.
Cardiac resynchronization therapy (CRT) is a validated HFREF therapy. Unfortunately 20 to 40 % of implanted patients according to the guidelines do not have an improvement in their condition. The detection of "non responders" is imperfect. The selection of eligible patients to cardiac resynchronization is defined by symptomatic patients (NYHA class II to IV), a reduced Left Ventricle ejection fraction and by the duration of the left bundle branch block. No other parameter (clinical, electrical, echocardiographical) have been identified as positive predictive factor to cardiac resynchronization therapy.
The aim of the investigators study is to identify positive predictive parameters to CRT.
The investigators study included all patients eligible to CRT according to the guidelines of the European Society of Cardiology in four French centers (Clermont-Ferrand, Bordeaux, Nancy, Pasteur Toulouse).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cardiac resynchronisation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac resynchronisation therapy | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite primary endpoint | to evaluate response to CRT, modifications in NYHA class, 6-MWT, LV volumes and QOL scale. | day of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality from any cause | at 6 months | |
| Cardiovascular Mortality | at 6 months | |
| Hospitalization for heart failure |
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Inclusion Criteria:
QRS ≥ 120 ms and LVEF ≤ 35% and appearance typical block left arm and NYHA III and IV in sinus rhythm, QRS ≥ 150 ms and LVEF ≤ 35 % non- appearance block left leg NYHA III and IV in sinus rhythm, QRS ≥ 130 ms and LVEF ≤ 30% and appearance typical of LBBB NYHA II
Exclusion Criteria:
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All patient eligible to cardiac resynchronisation therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Romain ESCHALIER | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| at 6 months |
| Mortality from heart failure | at 6 months |
| Hospitalization for other cardiac causes | at 6 months |
| Hospitalization for all causes | at 6 months |
| Sudden Death recovered | at 6 months |
| Use of vasoactive amines | at 6 months |
| Cardiac Transplantation | at 6 months |
| Test of 6-minute walk | at 6 months |
| NYHA Class | at 6 months |
| Quality of life ( MINNESOTA ) | at 6 months |
| Change in systolic and / or diastolic left ventricular volume greater than or equal to 15% off between the two periods | at 6 months |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D058406 | Cardiac Resynchronization Therapy |
| ID | Term |
|---|---|
| D002304 | Cardiac Pacing, Artificial |
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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