Cardiac Resynchronisation TherapyAXONE-Acute-2NCT04156412
AXONE-Acute II: 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 7 sites in 2 countries.
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
- 39 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 2 Jan 2020to 29 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
- Male or female patient aged ≥18 years old.
- Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines1.
- Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
- Signed and dated informed consent.
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 according to Modification of diet in renal disease formula (MDRD) < 30ml/mn/m²).
- Previous failure of 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.
- Vulnerable patient such as person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision).
- Known pregnancy, breastfeeding or women in childbearing age without an adequate contraceptive method with a known failure rate < 1%.-
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France5 sites
Bordeaux University Hospital
Bordeaux
Clermont-Ferrand University Hospital
Clermont-Ferrand
Lille University Hospital
Lille
Rennes University Hospital
Rennes
Rouen University Hospital
Rouen
Spain2 sites
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Universitario y Politécnico La Fe
Valencia
About this study
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 Bi-zone 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: 30 min
LV pacing success rate
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms.
Measured: 30 min
Secondary outcomes (8)
Device or Implant testing procedure-related Adverse Events
Measured: 1 month post intervention
Electrical performance (1)
LV pacing threshold (Volt)
Measured: 30 min
Electrical performance (2)
LV pacing impedance (Ohm)
Measured: 30 min
AXONE Implant Efficiency (1)
procedure time for successful placement
Measured: 30 min
AXONE Implant Efficiency (2)
fluoroscopic time
Measured: 30 min
AXONE Implant Efficiency (3)
radiation dose
Measured: 30 min
AXONE Implant Efficiency (4)
handling assessment.
Measured: 30 min
LV multipoint pacing success
the placement of the AXONE provides two pacing vectors matching
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start2 Jan 2020
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT04156412
- Sponsor's protocol ID
- 2019/127/HP
- Acronym
- AXONE-Acute-2
- Status last verified
- Feb 2026
- First submitted
- 5 Nov 2019
- Last updated
- 6 Feb 2026
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy
- ClinicalTrials.gov ID
- NCT04156412
- Acronym / sponsor ID
- AXONE-Acute-2 / 2019/127/HP
- Conditions
- Cardiac Resynchronisation Therapy
- Keywords
- quadripolar LV leads
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- MicroPort CRM
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 7 Nov 2019 (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
- Other
- 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 (4 listed)
- Male or female patient aged ≥18 years old.
- Patient presenting a CRT-P or CRT-D indication according to the latest ESC guidelines1.
- Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
- Signed and dated informed consent.
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 according to Modification of diet in renal disease formula (MDRD) < 30ml/mn/m²).
- Previous failure of 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 Bi-zone pacing success rate
Time frame: 30 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: 30 min
Percent of patients where the placement of the AXONE lead allows at least one LV pacing vectors matching: Pacing Threshold ≤ 3.5V/0.5ms.
8 secondary outcomes
Device or Implant testing procedure-related Adverse Events
Time frame: 1 month post intervention
Electrical performance (1)
Time frame: 30 min
Electrical performance (2)
Time frame: 30 min
AXONE Implant Efficiency (1)
Time frame: 30 min
AXONE Implant Efficiency (2)
Time frame: 30 min
AXONE Implant Efficiency (3)
Time frame: 30 min
AXONE Implant Efficiency (4)
Time frame: 30 min
LV multipoint pacing success
Time frame: 30 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 6 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiac Resynchronisation Therapy
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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
7 sites in 2 countries: 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 7 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 4 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Spain. 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 Bi-zone pacing success rate (time frame: 30 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?
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 6 Feb 2026.