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OpenTrials
Completed

NCT Number: NCT04156412

AXONE-Acute II: 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

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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 guidelines1.
  • Primary implant of a CRT device (including upgrade from a single or dual-chamber pacemaker or ICD).
  • Signed and dated informed consent.

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 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%.-

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 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.

  2. 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.

Secondary outcomes

  1. Device or Implant testing procedure-related Adverse Events

    Time frame: 1 month post intervention

  2. Electrical performance (1)

    Time frame: 30 min

    LV pacing threshold (Volt)

  3. Electrical performance (2)

    Time frame: 30 min

    LV pacing impedance (Ohm)

  4. AXONE Implant Efficiency (1)

    Time frame: 30 min

    procedure time for successful placement

  5. AXONE Implant Efficiency (2)

    Time frame: 30 min

    fluoroscopic time

  6. AXONE Implant Efficiency (3)

    Time frame: 30 min

    radiation dose

  7. AXONE Implant Efficiency (4)

    Time frame: 30 min

    handling assessment.

  8. LV multipoint pacing success

    Time frame: 30 min

    the placement of the AXONE provides two pacing vectors matching

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • MicroPort CRM

Registry information

Acronym: AXONE-Acute-2

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
Feb 6, 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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