Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-27

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Signals collection

Collection of sensors signals by the implanted device.

Group Type EXPERIMENTAL

Signals collection

Intervention Type DEVICE

A non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No