Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization TherapyCRT-MPPNCT04334018
Multi Point Pacing vs. Conventional STUDY PROTOCOL
A study testing conventional CRT and MPP CRT in people with Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy, run by CMC Ambroise Paré at 6 sites in 2 countries.
Trial summary
The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy
- What is being tested?
- conventional CRT and MPP CRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Mar 2018to 1 Mar 2023
- 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
- Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months
Who cannot join
- < 18 years and younger
- Pregnant or breastfeeding patients
- Non-LBBB patients (RBBB, intra-ventricular delay)
- Non-ambulatory NYHA class IV effort tolerance
- Myocardial infarction within 40 days before enrolment
- Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months
Show all 9Show fewer
- Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery)
- Patients with life expectancy of less than 12 months due to other medical conditions
- Patients who are involved in another investigational study (device or medical)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France5 sites
PHc hôpital d'Antibes la Fontonne
Antibes, 06606
Centre hospitalier de Cannes
Cannes, 06150
CMC Ambroise Paré
Neuilly-sur-Seine, 92200
CHU Nice
Nice, 06100
Centre Hospitalier de Perpignan
Perpignan, 66000
About this study
Official title: Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.
The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy
- Being tested
- conventional CRT, MPP CRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional CRTDevice
Conventional CRT or biventricular pacing "resynchronizes" left ventricular contraction by pacing the right and left ventricles (LV) simultaneously
MPP CRTDevice
CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously
| Study group | Role | What they receive |
|---|---|---|
| conventional CRT | Placebo comparator | Not described Receives: Device: conventional CRT |
| MPP CRT | Experimental | Not described Receives: Device: MPP CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome 1
To evaluate the clinical improvement of CRT MPP as compared to conventional CRT in Heart Failure patients with indication for CRT using automated intra-cardiac EGMs analysis (QuickOpt™) for device optimization, in a large multicentre international study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Mar 2018 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Why it stopped: Other studies on the same theme
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization TherapyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT04334018
- Sponsor's protocol ID
- 2017/02
- Acronym
- CRT-MPP
- Status last verified
- Apr 2020
- First submitted
- 31 Jan 2018
- Last updated
- 3 Apr 2020
- Results posted
- 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 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.
- ClinicalTrials.gov ID
- NCT04334018
- Acronym / sponsor ID
- CRT-MPP / 2017/02
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other studies on the same theme
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 3 Apr 2020 (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 this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional CRT | Placebo comparator | Device: conventional CRT |
| MPP CRT | Experimental | Device: MPP CRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months
Key exclusion criteria (9 listed)
- < 18 years and younger
- Pregnant or breastfeeding patients
- Non-LBBB patients (RBBB, intra-ventricular delay)
- Non-ambulatory NYHA class IV effort tolerance
- Myocardial infarction within 40 days before enrolment
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 |
|---|---|---|
| conventional CRTConventional CRT or biventricular pacing "resynchronizes" left ventricular contraction by pacing the right and left ventricles (LV) simultaneously | Device | conventional CRT |
| MPP CRTCRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously | Device | MPP CRT |
Primary outcome
Outcome 1
Time frame: 12 months
To evaluate the clinical improvement of CRT MPP as compared to conventional CRT in Heart Failure patients with indication for CRT using automated intra-cardiac EGMs analysis (QuickOpt™) for device optimization, in a large multicentre international study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: No
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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional CRT and MPP CRT in people with Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy, run by CMC Ambroise Paré at 6 sites in 2 countries.
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 1 inclusion and 9 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: withdrawn, as of the sponsor's last update on 3 Apr 2020. 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, Monaco. 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.
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?
Outcome 1 (time frame: 12 months). 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 3 Apr 2020.