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

Heart Failure Clinical Trial

— SATURN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019833
• Other study ID #: ICRI01
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: June 2022

Study information

• Verified date: March 2022
• Source: MicroPort CRM
• Contact: Alberto Borri Brunetto
• Phone: +39 335 6997104
• Email: alberto.borri.brunetto[@]crm.microport.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU Brest	Brest
France	CHU Dijon	Dijon
France	CHU La Timone	Marseille
France	CHU Rennes	Rennes
France	CHU St Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0)