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

March 22, 2022 updated by: MicroPort CRM
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • Chu Bordeaux
        • Contact:
          • Bordachar Pierre
        • Principal Investigator:
          • Bordachar Pierre, Pr
      • Brest, France
        • Recruiting
        • CHU Brest
        • Contact:
          • Mansourati Jacques
        • Principal Investigator:
          • Mansourati Jacques, Pr
      • Dijon, France
        • Recruiting
        • CHU Dijon
        • Principal Investigator:
          • Gabriel Laurent, Pr
        • Sub-Investigator:
          • Eicher Jean-Christophe, Pr
      • Marseille, France
        • Recruiting
        • CHU La Timone
        • Principal Investigator:
          • Habib Gilbert, Pr
        • Sub-Investigator:
          • Deharo Jean-Claude, Pr
      • Rennes, France
        • Recruiting
        • Chu Rennes
        • Principal Investigator:
          • Donal Erwan, Pr
        • Sub-Investigator:
          • Leclercq Christophe, Pr
      • Saint-Étienne, France
        • Recruiting
        • CHU ST Etienne
        • Contact:
          • Da Costa Antoine
        • Principal Investigator:
          • Da Costa Antoine, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Signals collection
Collection of sensors signals by the implanted device.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signals timing vs LPEI
Time Frame: 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.
Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

Investigators

  • Principal Investigator: Erwan Donal, Pr., CHU Pontchaillou - Rennes, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 27, 2022

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (ACTUAL)

August 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICRI01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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