AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy (AXONE-Acute-2)

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

Study Overview

• Status: Unknown
• Conditions: Cardiac Resynchronisation Therapy
• Intervention / Treatment: Device: Implant test procedure

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédéric ANSELME, Pr; Phone Number: 8990 +3323288; Email: frederic.anselme@chu-rouen.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • Bordeaux University Hospital
    • Contact: Philippe RITTER, Pr
  • Clermont-Ferrand, France
    • Recruiting
    • Clermont-Ferrand University Hospital
    • Contact: Frédéric Jean, MD
  • Lille, France
    • Recruiting
    • Lille University Hospital
    • Contact: Didier KLUG, Pr
  • Rennes, France
    • Recruiting
    • Rennes University Hospital
    • Contact: Christophe LECLERCQ, Pr
  • Rouen, France
    • Recruiting
    • Rouen University Hospital
• Spain
  • Badalona, Spain
    • Recruiting
    • Hospital Universitari Germans Trias i Pujol
    • Contact: Roger VILLUENDAS, MD
  • Valencia, Spain
    • Recruiting
    • Hospital Universitario y Politécnico La Fe
    • Contact: Joaquín OSCA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%.-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Implant test procedure; Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy	Device: Implant test procedure; Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 min

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: MicroPort CRM

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2020
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (ACTUAL): November 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: quadripolar LV leads
• Other Study ID Numbers: 2019/127/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No