An interventional study of Signals collection in Heart Failure, sponsored by MicroPort CRM. Status unknown at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by MicroPort CRM (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Other
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's planned enrollment of 35 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →MicroPort CRM is the lead sponsor of 25 studies on the registry; 4 are open to participants now.
First submitted after MicroPort CRM became part of MicroPort Scientific Corporation.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Collection of sensors signals by the implanted device.
Device: Signals collection
A non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals.
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.
Time frame: Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0)
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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