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

AXONE -Acute : 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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • Bordeaux University Hospital
  • Lille, France
    • Lille University Hospital
  • Rennes, France
    • Rennes University Hospital
  • Rouen, France
    • Rouen University Hospital

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 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%).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

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 Multizone 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	20 min
LV pacing success rate	Percent of patients where the placement of the AXONE lead allows at least one LV pacing vector matching Pacing Threshold ≤ 3.5V/0.5ms	20 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant testing Procedure-related Adverse Events procedure.		1 month post testing
Electrical performance of device (1)	Electrical performance focusing on LV pacing threshold (Volts)	20 min
Electrical performance of device (2)	Electrical performance focusing on LV pacing impedance (Ohm)	20 min
Lead Implant Efficiency	procedure time for successful placement	20 min
Lead Implant Efficiency	Radiation dose during implant	20 min
Satisfaction of implanter	handling assessment of implanter using satisfaction scale	20 min

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): December 13, 2018
• Study Completion (Actual): December 13, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: quadripolar LV leads
• Other Study ID Numbers: 2017/170/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