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Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.
The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.
This study is non-randomized, prospective, interventional, multicentric study. Patients who have been implanted with a CRT device between 6 and 18 months prior to inclusion and are considered non-responders are eligible for this study. CRT non-response can be clinical (lack of functional improvement or hospitalization for heart failure) and/or echocardiographic (insufficient improvement of LVEF and/or reduction of LVESV). Among exclusion criteria, permanent atrial fibrillation is of note.
Recruited patients will be submitted to an optimization procedure of their CRT device settings. This will be performed with a non-invasive method using the Finapress NOVA device, which records blood pressure with a digital cuff. The peak of blood pressure will correspond to the optimal device settings. The first step will be to chose the best pacing vector. The second step will be to chose the best AV delay. The best setting, i.e. associated with the highest blood pressure, will be programmed at the end of the optimization protocol.
The patients will be followed at 6 months with clinical evaluation and echocardiography to assess the conversion rate of non-responders to responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-responders to CRT | Experimental | Non-responders to CRT who will undergo an electrical optimization of the settings of their device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device programming of CRT pacemaker or defibrillator | Device | Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic response | Highest Systolic Blood Pressure (SBP) obtained by stimulation vector | During the optimization session |
| Measure | Description | Time Frame |
|---|---|---|
| echocardiographic response | Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV) | at 6 months of follow-up |
| Clinical response |
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Inclusion Criteria:
Clinical criteria (Packer classification):
Lack of improvement of NYHA functional class And/or hospitalization for heart failure
Echocardiographic criteria:
Lack of improvement of LVEF > 5points And/or reduction of LVESV < 15%
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHEM Eaubonne | Montmorency | 95160 | France | |||
| CHU de Poitiers |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D047548 | Defibrillators |
| ID | Term |
|---|---|
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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Hospitalization for heart failure
| at 6 months of follow up |
| Poitiers |
| 86021 |
| France |
| CMC Ambroise Paré | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |