NCT04156412

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2020

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

November 5, 2019

Last Update Submit

February 5, 2026

Conditions

Cardiac Resynchronisation Therapy

Keywords

quadripolar LV leads

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Device or Implant testing procedure-related Adverse Events

    1 month post intervention

  • Electrical performance (1)

    30 min

  • Electrical performance (2)

    30 min

  • AXONE Implant Efficiency (1)

    30 min

  • AXONE Implant Efficiency (2)

    30 min

  • +3 more secondary outcomes

Study Arms (1)

Implant test procedure

EXPERIMENTAL

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

Device: Implant test procedure

Interventions

Implant test procedureDEVICE

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

Implant test procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bordeaux University Hospital

Bordeaux, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Location

Lille University Hospital

Lille, France

Location

Rennes University Hospital

Rennes, France

Location

Rouen University Hospital

Rouen, France

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

Study Officials

  • Frédéric ANSELME, Pr

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

January 2, 2020

Primary Completion

September 29, 2020

Study Completion

September 29, 2020

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)ES(2)