Heart Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESignals collection
A non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals.
Sponsors
MicroPort CRM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with class I or II indication for implantation of a CRT-D device according to current ESC guidelines * Patient newly implanted with a MicroPort CRM Platinium CRT-D SonR or Platinium CRT-D device within 2 months before the Investigational Procedure * Patient in sinus rhythm with a preserved atrio-ventricular conduction, and PR interval=220 +/- 30 ms on surface ECG * Patient has reviewed, signed and dated the study informed consent form
Exclusion criteria
* Patient with permanent or persistent atrial fibrillation or atrial flutter * Patient presenting with a permanent or frequent paroxysmal high degree atrio-ventricular block * Device upgrade or replacement * Minor patient (i.e. under 18 years of age), or patient under guardianship or kept in detention * Patient unavailable for the scheduled Investigational Procedure, not able to understand the purpose of this study or refusing to cooperate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Signals timing vs LPEI | Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0) | 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. |
Countries
France
Contacts
Primary ContactAlberto Borri Brunetto
Outcome results
None listed