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OpenTrials
Completed

NCT Number: NCT03750058

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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%).

Treatment and study plan

Implant test procedure

Device

Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Implant testing Procedure-related Adverse Events procedure.

    Time frame: 1 month post testing

  2. Electrical performance of device (1)

    Time frame: 20 min

    Electrical performance focusing on LV pacing threshold (Volts)

  3. Electrical performance of device (2)

    Time frame: 20 min

    Electrical performance focusing on LV pacing impedance (Ohm)

  4. Lead Implant Efficiency

    Time frame: 20 min

    procedure time for successful placement

  5. Lead Implant Efficiency

    Time frame: 20 min

    Radiation dose during implant

  6. Satisfaction of implanter

    Time frame: 20 min

    handling assessment of implanter using satisfaction scale

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • MicroPort CRM

Registry information

Official study title

AXONE -Acute : Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

Acronym: AXONE-Acute

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2018
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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