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

Not Applicable

• Conditions: Cardiac Resynchronisation Therapy
• Interventions: Device: Implant test procedure

• Registration Number: NCT04156412
• Lead Sponsor: University Hospital, Rouen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-07
• Study Start: 2020-01-02
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-29
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
LV Bi-zone pacing success rate	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	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 Outcome Measures

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

Trial Locations

Locations (7)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Rennes University Hospital; 🇫🇷 Rennes, France

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Lille University Hospital; 🇫🇷 Lille, France

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Rouen University Hospital; 🇫🇷 Rouen, France