Heart FailureSATURNNCT05019833
Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN
A study testing Signals collection in people with Heart Failure, run by MicroPort CRM at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Signals collection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 6 sitesFrance
- Study dates
- 27 Jan 2022to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Bordachar Pierre
Bordachar Pierre, Pr
- Recruiting
CHU Brest
Brest
Mansourati Jacques
Mansourati Jacques, Pr
- Recruiting
CHU Dijon
Dijon
Gabriel Laurent, Pr
Eicher Jean-Christophe, Pr
- Recruiting
CHU La Timone
Marseille
Habib Gilbert
Habib Gilbert, Pr
- Recruiting
CHU Rennes
Rennes
Donal Erwan
Donal Erwan, Pr
- Recruiting
CHU St Etienne
Saint-Etienne
Da Costa Antoine
Da Costa Antoine, Pr
About this 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, in CRT patients.
Read the 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
- Being tested
- Signals collection
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signals collectionDevice
A non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals.
| Study group | Role | What they receive |
|---|---|---|
| Signals collection | Experimental | Collection of sensors signals by the implanted device. Receives: Device: Signals collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start27 Jan 2022
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erwan Donal, Pr., Principal investigator, CHU Pontchaillou - Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019833
- Sponsor's protocol ID
- ICRI01
- Acronym
- SATURN
- Status last verified
- Mar 2022
- First submitted
- 28 Jul 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of SPOT EGMs And inTra-Cardiac Impedance for Atrio-ventricUlar and inteR-ventricular Delays optimizatioN
- ClinicalTrials.gov ID
- NCT05019833
- Acronym / sponsor ID
- SATURN / ICRI01
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Signals collection | Experimental | Device: Signals collectionCollection of sensors signals by the implanted device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Signals collectionA non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals. | Device | Signals collection |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwan Donal, Pr. principal investigator
CHU Pontchaillou - Rennes, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Signals collection in people with Heart Failure, run by MicroPort CRM at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Borri Brunetto (+39 335 6997104, alberto.borri.brunetto@crm.microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signals timing vs LPEI (time frame: Participants will be tested during a single clinic visit, at the enrolment in the study (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.