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Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard BIV | the following group describes the effects of the left ventricular stimulation involving a dipole of two electrodes located inside a suitable vessel branch of the coronary sinus (CS). Standard BIV pacing modality can be achieved by either a quadripolar electrode implanted in the CS, of which only two poles will be used for cardiac resynchronization therapy, or by a bipolar electrode equipped with just two electrodes. The latter describes the old technology, requiring a change into typology of generator which has to display an IS-1 connection (due to different distal terminal of the electrode itself), instead of the new one IS-4 connection that has been developed for quadripolar electrodes. | ||
| MPP BIV | Such modality of left ventricular stimulation requires a dynamic use of the four electrodes located in the proximal segment of the electrocatheter that allows the recruitment of a vast area of the left ventricle. It is limited by the presence of scars on left ventricle surface, or phrenic nerve inadvertent stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy device programming | Device | Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively |
| Measure | Description | Time Frame |
|---|---|---|
| Acute improvement in cardiac function (1) | change in dP/dtmax, expressed in mmHg/s, assessed through photoplethysmography. This assessment represents in a non-invasive fashion, the rise in pressure (P) developed inside left ventricle during contraction over time. | 24-48 hours after CRT-D implantation |
| Acute improvement in cardiac function (2) | change in global longitudinal strain, assessed through echocardiography. This assessment elucidates longitudinal shortening of the left ventricle as a percentage (change in length as a proportion to baseline length). GLS is derived from speckle tracking, and analyzed by post-processing of apical images of the left ventricle. | 24-48 hours after CRT-D implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Delayed response (1) | change in GLS. Participants will investigate whether left ventricular remodeling upon "patient-tailored" biventricular stimulation will behave differentially according to type of stimulation; the total amount of CRT-responder patients will be therefore considered | 3 Months |
| Delayed response (2) |
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Inclusion Criteria:
Exclusion Criteria:
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- Patients with standard indications to CRT satisfying the study Inclusion and Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Policlinico Mater Domini | Catanzaro | CZ | 88100 | Italy | ||
| AO Cardarelli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38237796 | Derived | Passafaro F, Rapacciuolo A, Ruocco A, Ammirati G, Crispo S, Pasceri E, Santarpia G, Mauro C, Esposito G, Indolfi C, Curcio A. COMPArison of Multi-Point Pacing and ConvenTional Cardiac Resynchronization Therapy Through Noninvasive Hemodynamics Measurement: Short- and Long-Term Results of the COMPACT-MPP Study. Am J Cardiol. 2024 Mar 15;215:42-49. doi: 10.1016/j.amjcard.2023.12.057. Epub 2024 Jan 17. |
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change in NYHA class. Participants will check if functional status will change after optimized biventricular stimulation therapy and will provide clinical data on CRT responders. |
| 3 Months |
| Naples |
| 80100 |
| Italy |
| AOU Federico II | Naples | 80100 | Italy |