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

Overview

Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2020

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Device or Implant testing procedure-related Adverse Events
    • Time Frame: 1 month post intervention
  • Electrical performance (1)
    • Time Frame: 30 min
    • LV pacing threshold (Volt)
  • Electrical performance (2)
    • Time Frame: 30 min
    • LV pacing impedance (Ohm)
  • AXONE Implant Efficiency (1)
    • Time Frame: 30 min
    • procedure time for successful placement
  • AXONE Implant Efficiency (2)
    • Time Frame: 30 min
    • fluoroscopic time
  • AXONE Implant Efficiency (3)
    • Time Frame: 30 min
    • radiation dose
  • AXONE Implant Efficiency (4)
    • Time Frame: 30 min
    • handling assessment.
  • LV multipoint pacing success
    • Time Frame: 30 min
    • the placement of the AXONE provides two pacing vectors matching

Participating in This Clinical Trial

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%.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Rouen
  • Collaborator
    • MicroPort CRM
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Frédéric ANSELME, Pr, Principal Investigator, Rouen University Hospital
  • Overall Contact(s)
    • Frédéric ANSELME, Pr, +3323288, frederic.anselme@chu-rouen.fr

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