Heart Failure3 STIMNCT03779802
Prospective Multicentric Study Comparing the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization Therapy Recipients
A study testing Device programming of ABBOTT CRT pacemaker or defibrillator in people with Heart Failure and Cardiac Resynchronization Therapy, run by CMC Ambroise Paré at 3 sites in France.
Trial summary
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Resynchronization Therapy
- What is being tested?
- Device programming of ABBOTT CRT pacemaker or defibrillator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 23 Apr 2019to 18 Apr 2020
- 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 older than 18
- Implantation of a CRT (CRT-P or CRT-D) less than 3 months before inclusion
- MPP and SyncAV-enabled ABBOTT Quadripolar CRT pacing system
- Patient who had signed an informed consent and is willing to comply with study requirements
- De novo implantation
- Patient covered by national healthcare insurance
Who cannot join
- Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia
- Pacing indication for 2nd or 3rd degree AV block
- Upgrading from non-CRT system
- Pregnant or breastfeeding women
- Adult under legal protection
Trial locations and contacts
3 sites in 1 country.
France3 sites
Gehm Site D'Eaubonne
Eaubonne, Val-d'Oise, 95600
Cmc Ambroise Pare
Neuilly-sur-Seine, 92200
CHU Poitiers
Poitiers
About this study
Official title: Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality.
Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.
The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.
Read the detailed description
This study is a non-randomized, prospective, interventional, multicentric study.
Patients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months are eligible for the study.
Recruited patients will be submitted to a non-invasive evaluation of different pacing modes. This will be performed using the Finapress NOVA device, which records blood pressure with a digital cuff. The peak of blood pressure will correspond to the optimal device settings
Three modes of stimulation of ABBOTT CRT devices will be compared:
- Classical bi-ventricular pacing mode at nominal value and with AV delay optimization
- SyncAV mode at nominal value or with left ventricular preexcitation optimization
- Multipoint Pacing (MPP) mode, alone or in combination with SyncAV mode This is an acute evaluation study without scheduled follow-up.
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Being tested
- Device programming of ABBOTT CRT pacemaker or defibrillator
- Keywords
- Cardiac Resynchronization Therapy, Atrioventricular delay optimization, Multipoint pacing, Negative atrioventricular hysteresis, Non invasive hemodynamic optimization, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device programming of ABBOTT CRT pacemaker or defibrillatorOther
Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session.
| Study group | Role | What they receive |
|---|---|---|
| CRT device | Experimental | Patients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes Receives: Other: Device programming of ABBOTT CRT pacemaker or defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic response
Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation
Measured: day 0
Secondary outcomes (3)
Other hemodynamical response
Cardiac output
Measured: day 0
Other hemodynamical response
Systolic ejection volume
Measured: day 0
Other hemodynamical response
dP/dT
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start23 Apr 2019
- Primary completion18 Apr 2020
- Study completion18 Apr 2020
Why it stopped: With the current health situation, we do not anticipate a significant resumption of recruitment for several months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghassan MD MOUBARAK, Principal investigator, CMC Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779802
- Sponsor's protocol ID
- 2018/10
- Acronym
- 3 STIM
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2018
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moubarak G, Sebag FA, Socie P, Villejoubert O, Louembe J, Ferchaud V. Interrelationships between interventricular electrical delays in cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2020 Sep;31(9):2405-2414. doi: 10.1111/jce.14629. Epub 2020 Jun 29.
PubMed 32562444Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30.
PubMed 33128179
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.
- ClinicalTrials.gov ID
- NCT03779802
- Acronym / sponsor ID
- 3 STIM / 2018/10
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Keywords
- Cardiac Resynchronization Therapy, Atrioventricular delay optimization, Multipoint pacing, Negative atrioventricular hysteresis, Non invasive hemodynamic optimization, Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: With the current health situation, we do not anticipate a significant resumption of recruitment for several months.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 19 Dec 2018 (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.
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality.
Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.
The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.
Detailed description
This study is a non-randomized, prospective, interventional, multicentric study.
Patients implanted with an Abbott ® CRT pacemaker or defibrillator since less than 3 months are eligible for the study.
Recruited patients will be submitted to a non-invasive evaluation of different pacing modes. This will be performed using the Finapress NOVA device, which records blood pressure with a digital cuff. The peak of blood pressure will correspond to the optimal device settings
Three modes of stimulation of ABBOTT CRT devices will be compared:
- Classical bi-ventricular pacing mode at nominal value and with AV delay optimization
- SyncAV mode at nominal value or with left ventricular preexcitation optimization
- Multipoint Pacing (MPP) mode, alone or in combination with SyncAV mode This is an acute evaluation study without scheduled follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT device | Experimental | Other: Device programming of ABBOTT CRT pacemaker or defibrillatorPatients implanted with a CRT device who will undergo a non-invasive hemodynamic evaluation of different pacing modes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient older than 18
- Implantation of a CRT (CRT-P or CRT-D) less than 3 months before inclusion
- MPP and SyncAV-enabled ABBOTT Quadripolar CRT pacing system
- Patient who had signed an informed consent and is willing to comply with study requirements
- De novo implantation
Key exclusion criteria (5 listed)
- Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia
- Pacing indication for 2nd or 3rd degree AV block
- Upgrading from non-CRT system
- Pregnant or breastfeeding women
- Adult under legal protection
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 |
|---|---|---|
| Device programming of ABBOTT CRT pacemaker or defibrillatorComparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session. | Other | CRT device |
Primary outcome
Hemodynamic response
Time frame: day 0
Highest Systolic Blood Pressure (SBP) obtained by optimization of the mode of stimulation
3 secondary outcomes
Other hemodynamical response
Time frame: day 0
Other hemodynamical response
Time frame: day 0
Other hemodynamical response
Time frame: day 0
Results and safety
The study was stopped early (reason given: With the current health situation, we do not anticipate a significant resumption of recruitment for several months.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Results publication: PubMed 32562444Moubarak G, Sebag FA, Socie P, Villejoubert O, Louembe J, Ferchaud V. Interrelationships between interventricular electrical delays in cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2020 Sep;31(9):2405-2414. doi: 10.1111/jce.14629. Epub 2020 Jun 29.
- Derived from this study: PubMed 33128179Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30.
- 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.
Ghassan MD MOUBARAK principal investigator
CMC Ambroise Paré
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device programming of ABBOTT CRT pacemaker or defibrillator in people with Heart Failure and Cardiac Resynchronization Therapy, run by CMC Ambroise Paré at 3 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 6 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: stopped early, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was stopped early (reason given: With the current health situation, we do not anticipate a significant resumption of recruitment for several months.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic response (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03779802, which also lists 2 linked publications.
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 7 Apr 2026.