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With the current health situation, we do not anticipate a significant resumption of recruitment for several months.
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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.
Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.
The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.
This study is a non-randomized, prospective, interventional, multicentric study.
Patients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months are eligible for the study.
Recruited patients will be submitted to a non-invasive evaluation of different pacing modes. This will be performed 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
Three modes of stimulation of ABBOTT CRT devices will be compared:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT device | Experimental | Patients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device programming of ABBOTT CRT pacemaker or defibrillator | Other | Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic response | Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation | day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Other hemodynamical response | Cardiac output | day 0 |
| Other hemodynamical response | Systolic ejection volume | day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghassan MD MOUBARAK | CMC Ambroise Paré | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gehm Site D'Eaubonne | Eaubonne | Val-d'Oise | 95600 | France | ||
| Cmc Ambroise Pare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32562444 | Result | Moubarak G, Sebag FA, Socie P, Villejoubert O, Louembe J, Ferchaud V. Interrelationships between interventricular electrical delays in cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2020 Sep;31(9):2405-2414. doi: 10.1111/jce.14629. Epub 2020 Jun 29. | |
| 33128179 | Derived | Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30. |
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|
| Other hemodynamical response | dP/dT | day 0 |
| Neuilly-sur-Seine |
| 92200 |
| France |
| CHU Poitiers | Poitiers | France |
| 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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