Cardiac Resynchronisation TherapyAXONE-AcuteNCT03750058
Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
A study testing Implant test procedure in people with Cardiac Resynchronisation Therapy, run by University Hospital, Rouen at 4 sites in France.
Trial summary
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronisation Therapy
- What is being tested?
- Implant test procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Aug 2018to 13 Dec 2018
- 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
- Male or female patient aged ≥18 years old.
- Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines .
- Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
- Signed and dated informed consent.
- Patient affiliated with, or beneficiary of a social security category.
Who cannot join
- Class IV of NYHA (ambulatory or not).
- Allergy to contrast media used for imaging during cardiac catheterization.
- Severe Renal Failure (clearance of creatinine < 30ml/mn/m²).
- Previous failure catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
- Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
- Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
- Known pregnancy, breastfeeding women or in childbearing age without an adequate contraceptive method (failure rate < 1%).
Trial locations and contacts
4 sites in 1 country.
France4 sites
Bordeaux University Hospital
Bordeaux
Lille University Hospital
Lille
Rennes University Hospital
Rennes
Rouen University Hospital
Rouen
About this study
Official title: AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
- Conditions
- Cardiac Resynchronisation Therapy
- Being tested
- Implant test procedure
- Keywords
- quadripolar LV leads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant test procedureDevice
Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
| Study group | Role | What they receive |
|---|---|---|
| Implant test procedure | Experimental | Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy Receives: Device: Implant test procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV Multizone pacing success rate
Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms
Measured: 20 min
LV pacing success rate
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms
Measured: 20 min
Secondary outcomes (6)
Implant testing Procedure-related Adverse Events procedure.
Measured: 1 month post testing
Electrical performance of device (1)
Electrical performance focusing on LV pacing threshold (Volts)
Measured: 20 min
Electrical performance of device (2)
Electrical performance focusing on LV pacing impedance (Ohm)
Measured: 20 min
Lead Implant Efficiency
procedure time for successful placement
Measured: 20 min
Lead Implant Efficiency
Radiation dose during implant
Measured: 20 min
Satisfaction of implanter
handling assessment of implanter using satisfaction scale
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start8 Aug 2018
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Resynchronisation TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- MicroPort CRM
- Responsible party
- Sponsor
- Investigators
- Frédéric ANSELME, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750058
- Sponsor's protocol ID
- 2017/170/HP
- Acronym
- AXONE-Acute
- Status last verified
- Feb 2019
- First submitted
- 27 Jul 2018
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anselme F, Albatat M, Marquie C, Leclercq C, Ritter P, Ollivier JF, Shan N, Ziglio F, Feuerstein D. Exploring a New Systematic Route for Left Ventricular Pacing in Cardiac Resynchronization Therapy. Circ J. 2021 Feb 25;85(3):283-290. doi: 10.1253/circj.CJ-20-0266. Epub 2021 Jan 27.
PubMed 33504741
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
- ClinicalTrials.gov ID
- NCT03750058
- Acronym / sponsor ID
- AXONE-Acute / 2017/170/HP
- Conditions
- Cardiac Resynchronisation Therapy
- Keywords
- quadripolar LV leads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- MicroPort CRM
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 21 Nov 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.
Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant test procedure | Experimental | Device: Implant test procedureImplant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient aged ≥18 years old.
- Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines .
- Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
- Signed and dated informed consent.
- Patient affiliated with, or beneficiary of a social security category.
Key exclusion criteria (7 listed)
- Class IV of NYHA (ambulatory or not).
- Allergy to contrast media used for imaging during cardiac catheterization.
- Severe Renal Failure (clearance of creatinine < 30ml/mn/m²).
- Previous failure catheterization of the coronary sinus, or previous failure of left ventricular lead implantation.
- Already included in another clinical study involving intra-cardiac active implantable device, or participation to any other clinical trial in the last 2 weeks.
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 |
|---|---|---|
| Implant test procedureImplant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy | Device | Implant test procedure |
Primary outcome
LV Multizone pacing success rate
Time frame: 20 min
Percent of patients where the placement of the AXONE lead provides two distant LV pacing vectors matching Pacing Threshold ≤ 3.5V/0.5ms
LV pacing success rate
Time frame: 20 min
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms
6 secondary outcomes
Implant testing Procedure-related Adverse Events procedure.
Time frame: 1 month post testing
Electrical performance of device (1)
Time frame: 20 min
Electrical performance of device (2)
Time frame: 20 min
Lead Implant Efficiency
Time frame: 20 min
Lead Implant Efficiency
Time frame: 20 min
Satisfaction of implanter
Time frame: 20 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Results publication: PubMed 33504741Anselme F, Albatat M, Marquie C, Leclercq C, Ritter P, Ollivier JF, Shan N, Ziglio F, Feuerstein D. Exploring a New Systematic Route for Left Ventricular Pacing in Cardiac Resynchronization Therapy. Circ J. 2021 Feb 25;85(3):283-290. doi: 10.1253/circj.CJ-20-0266. Epub 2021 Jan 27.
- 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.
Frédéric ANSELME, Pr principal investigator
University Hospital, Rouen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant test procedure in people with Cardiac Resynchronisation Therapy, run by University Hospital, Rouen at 4 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 20 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 4 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LV Multizone pacing success rate (time frame: 20 min). The study lists 2 primary outcomes in all. 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 NCT03750058, which also lists 1 linked publication.
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 20 Apr 2026.