NCT05019833

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-27
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-08-25
• Last updated: 2022-04-04

Locations

6 sites across 1 country: France