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

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: Signals collection

• Registration Number: NCT05019833
• Lead Sponsor: MicroPort CRM

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.

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-25
• Study Start: 2022-01-27
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-04
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Signals collection	Signals collection	Collection of sensors signals by the implanted device.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

CHU Brest; 🇫🇷 Brest, France

CHU Dijon; 🇫🇷 Dijon, France

CHU La Timone; 🇫🇷 Marseille, France

CHU St Etienne; 🇫🇷 Saint-Étienne, France

CHU Rennes; 🇫🇷 Rennes, France

CHU Bordeaux; 🇫🇷 Bordeaux, France