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

Primary Purpose

Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Signals collection

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU BordeauxRecruiting
CHU BrestRecruiting
CHU DijonRecruiting
CHU La TimoneRecruiting
CHU RennesRecruiting
CHU St EtienneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Signals collection

Arm Description

Collection of sensors signals by the implanted device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05019833

First Posted

July 28, 2021

Last Updated

March 22, 2022

Sponsor

MicroPort CRM

1. Study Identification

Unique Protocol Identification Number

NCT05019833

Brief Title

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

Acronym

SATURN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 27, 2022 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MicroPort CRM

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Signals collection

Arm Type

Experimental

Arm Description

Collection of sensors signals by the implanted device.

Intervention Type

Device

Intervention Name(s)

Signals collection

Intervention Description

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

Primary Outcome Measure Information:

Title

Signals timing vs LPEI

Description

Time Frame

Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alberto Borri Brunetto

Phone

+39 335 6997104

alberto.borri.brunetto@crm.microport.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erwan Donal, Pr.

Organizational Affiliation

CHU Pontchaillou - Rennes, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Bordeaux

City

Bordeaux

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bordachar Pierre

First Name & Middle Initial & Last Name & Degree

Bordachar Pierre, Pr

Facility Name

CHU Brest

City

Brest

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mansourati Jacques

First Name & Middle Initial & Last Name & Degree

Mansourati Jacques, Pr

Facility Name

CHU Dijon

City

Dijon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabriel Laurent, Pr

First Name & Middle Initial & Last Name & Degree

Eicher Jean-Christophe, Pr

Facility Name

CHU La Timone

City

Marseille

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Habib Gilbert

First Name & Middle Initial & Last Name & Degree

Habib Gilbert, Pr

First Name & Middle Initial & Last Name & Degree

Deharo Jean-Claude, Pr

Facility Name

CHU Rennes

City

Rennes

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Donal Erwan

First Name & Middle Initial & Last Name & Degree

Donal Erwan, Pr

First Name & Middle Initial & Last Name & Degree

Leclercq Christophe, Pr

Facility Name

CHU St Etienne

City

Saint-Étienne

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Da Costa Antoine

First Name & Middle Initial & Last Name & Degree

Da Costa Antoine, Pr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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