Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN
SATURN
1 other identifier
interventional
35
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started Jan 2022
Shorter than P25 for not_applicable heart-failure
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedStudy Start
First participant enrolled
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedApril 4, 2022
March 1, 2022
4 months
July 28, 2021
March 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Signals collection
EXPERIMENTALCollection of sensors signals by the implanted device.
Interventions
A non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MicroPort CRMlead
Study Sites (6)
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-Etienne, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erwan Donal, Pr.
CHU Pontchaillou - Rennes, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2021
First Posted
August 25, 2021
Study Start
January 27, 2022
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
April 4, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share