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The purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters, in CRT patients.
The SATURN study is a prospective, interventional, open-label, non-randomized, single-arm, acute, multicenter feasibility study.
The purpose of the study is to collect data from the two implanted sensors simultaneously to the surface ECG and echocardiographic measurements of electromechanical parameters.
The data collected will be analysed in order to explore the relevance of timings and morphological features derived from those signals in comparison with timings determined on echocardiography and electrocardiograms (ECG) in various configurations of atrioventricular (AV) and inter-ventricular (VV) delays.
A maximum of 35 subjects, implanted with a CRT-D device, will be enrolled, at approximately 6 sites in France. Each patient will participate to this study only during an echocardiographic procedure, whose duration is estimated in approximately 1.5 hour.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Signals collection | Experimental | Collection of sensors signals by the implanted device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Signals collection | Device | A non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals. |
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| Measure | Description | Time Frame |
|---|---|---|
| Signals timing vs LPEI | An exploratory analysis on the relation between timings derived from the signals acquired with CRT implanted devices, and LPEI (Left Pre-Ejection Interval) determined by echography in multiple configurations of atrio-ventricular (AV) and inter-ventricular (VV) delays. | Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alberto Borri Brunetto | Contact | +39 335 6997104 | alberto.borri.brunetto@crm.microport.com |
| Name | Affiliation | Role |
|---|---|---|
| Erwan Donal, Pr. | CHU Pontchaillou - Rennes, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Recruiting | Bordeaux | France |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| CHU Brest | Recruiting | Brest | France |
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| CHU Dijon | Recruiting | Dijon | France |
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| CHU La Timone | Recruiting | Marseille | France |
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| CHU Rennes | Recruiting | Rennes | France |
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| CHU St Etienne | Recruiting | Saint-Etienne | France |
|