Heart FailureOPTIREGNCT03789487
Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
A study testing Device programming of 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. However, one-third of patients are non-responders. 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 CRT pacemaker or defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Feb 2019to 14 Sep 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
- Patient implanted with a CRT (CRT-P or CRT-D) more than 6 months but less than 18 months before inclusion
- Non-responder patients:
- Clinical criteria (Packer classification):
- Lack of improvement of NYHA functional class And/or hospitalization for heart failure
- Echocardiographic criteria:
Show all 9Show fewer
- Lack of improvement of LVEF > 5points And/or reduction of LVESV < 15%
- Patient who had signed an informed consent and is willing to comply with study requirements
- Patient covered by French national healthcare insurance
Who cannot join
- Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia
- Scheduled hospitalization for major cardiac intervention or cardiac surgery in the 6 coming months
- Life-expectancy of less than 6 months
- Pregnant or breastfeeding women
- Adults under legal protection
Trial locations and contacts
3 sites in 1 country.
France3 sites
GHEM Eaubonne
Montmorency, 95160
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200
CHU de Poitiers
Poitiers, 86021
About this study
Official title: Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
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. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.
The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.
Read the detailed description
This study is non-randomized, prospective, interventional, multicentric study. Patients who have been implanted with a CRT device between 6 and 18 months prior to inclusion and are considered non-responders are eligible for this study. CRT non-response can be clinical (lack of functional improvement or hospitalization for heart failure) and/or echocardiographic (insufficient improvement of LVEF and/or reduction of LVESV). Among exclusion criteria, permanent atrial fibrillation is of note.
Recruited patients will be submitted to an optimization procedure of their CRT device settings. This will be performed with a non-invasive method 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. The first step will be to chose the best pacing vector. The second step will be to chose the best AV delay. The best setting, i.e. associated with the highest blood pressure, will be programmed at the end of the optimization protocol.
The patients will be followed at 6 months with clinical evaluation and echocardiography to assess the conversion rate of non-responders to responders.
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Being tested
- Device programming of CRT pacemaker or defibrillator
- Keywords
- Cardiac Resynchronization Therapy, Non-responders, Pacing vector optimization, Atrioventricular delay optimization, 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 CRT pacemaker or defibrillatorDevice
Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device
| Study group | Role | What they receive |
|---|---|---|
| Non-responders to CRT | Experimental | Non-responders to CRT who will undergo an electrical optimization of the settings of their device Receives: Device: Device programming of 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 stimulation vector
Measured: During the optimization session
Secondary outcomes (2)
echocardiographic response
Left Ventricular Ejection Fraction (LVEF), Left Ventricular end-diastolic Volume (LVEDV), Left Ventricular End-Systolic Volume (LVESV)
Measured: at 6 months of follow-up
Clinical response
Hospitalization for heart failure
Measured: at 6 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start22 Feb 2019
- Primary completion21 Aug 2020
- Study completion14 Sep 2020
Why it stopped: the end of inclusion period
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789487
- Sponsor's protocol ID
- 2018/09
- Acronym
- OPTIREG
- Status last verified
- Jan 2021
- First submitted
- 17 Dec 2018
- Last updated
- 27 Jan 2021
- 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 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Study of Electrical Optimization of Cardiac Resynchronization Therapy in Non-responder Patients
- ClinicalTrials.gov ID
- NCT03789487
- Acronym / sponsor ID
- OPTIREG / 2018/09
- Conditions
- Heart Failure, Cardiac Resynchronization Therapy
- Keywords
- Cardiac Resynchronization Therapy, Non-responders, Pacing vector optimization, Atrioventricular delay optimization, Non invasive hemodynamic optimization, Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the end of inclusion period
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 28 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. However, one-third of patients are non-responders. Among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (AV) delay, is an important cause.
The aim of the study is to investigate whether the optimization of CRT settings (pacing vector and AV delay) results in improved clinical and echocardiographic outcomes in a non-responder CRT population after 6 months of therapy.
Detailed description
This study is non-randomized, prospective, interventional, multicentric study. Patients who have been implanted with a CRT device between 6 and 18 months prior to inclusion and are considered non-responders are eligible for this study. CRT non-response can be clinical (lack of functional improvement or hospitalization for heart failure) and/or echocardiographic (insufficient improvement of LVEF and/or reduction of LVESV). Among exclusion criteria, permanent atrial fibrillation is of note.
Recruited patients will be submitted to an optimization procedure of their CRT device settings. This will be performed with a non-invasive method 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. The first step will be to chose the best pacing vector. The second step will be to chose the best AV delay. The best setting, i.e. associated with the highest blood pressure, will be programmed at the end of the optimization protocol.
The patients will be followed at 6 months with clinical evaluation and echocardiography to assess the conversion rate of non-responders to responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-responders to CRT | Experimental | Device: Device programming of CRT pacemaker or defibrillatorNon-responders to CRT who will undergo an electrical optimization of the settings of their device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient older than 18
- Patient implanted with a CRT (CRT-P or CRT-D) more than 6 months but less than 18 months before inclusion
- Non-responder patients:
- Lack of improvement of NYHA functional class And/or hospitalization for heart failure
- Lack of improvement of LVEF > 5points And/or reduction of LVESV < 15%
Key exclusion criteria (5 listed)
- Permanent/persistant atrial fibrillation/ supra-ventricular tachycardia
- Scheduled hospitalization for major cardiac intervention or cardiac surgery in the 6 coming months
- Life-expectancy of less than 6 months
- Pregnant or breastfeeding women
- Adults 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 CRT pacemaker or defibrillatorStimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device | Device | Non-responders to CRT |
Primary outcome
Hemodynamic response
Time frame: During the optimization session
Highest Systolic Blood Pressure (SBP) obtained by stimulation vector
2 secondary outcomes
echocardiographic response
Time frame: at 6 months of follow-up
Clinical response
Time frame: at 6 months of follow up
Results and safety
The study was stopped early (reason given: the end of inclusion period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 9 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 27 Jan 2021. 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: the end of inclusion period). 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: During the optimization session). 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 27 Jan 2021.