Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

Not Applicable

Completed

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

• Registration Number: NCT03750058
• 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: 2018-07-27
• Study Start: 2018-08-08
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Primary Completion: 2018-12-13
• Study Completion: 2018-12-13
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France

Rennes University Hospital; 🇫🇷 Rennes, France

Lille University Hospital; 🇫🇷 Lille, France

Rouen University Hospital; 🇫🇷 Rouen, France