NCT03750058

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

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 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

July 27, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

August 8, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

April 20, 2026

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

July 27, 2018

Last Update Submit

April 16, 2026

Conditions

Cardiac Resynchronisation Therapy

Keywords

quadripolar LV leads

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Implant testing Procedure-related Adverse Events procedure.

    1 month post testing

  • Electrical performance of device (1)

    20 min

  • Electrical performance of device (2)

    20 min

  • Lead Implant Efficiency

    20 min

  • Lead Implant Efficiency

    20 min

  • +1 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 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.

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 \< 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%).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bordeaux University Hospital

Bordeaux, France

Location

Lille University Hospital

Lille, France

Location

Rennes University Hospital

Rennes, France

Location

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

  • Anselme F, Albatat M, Marquie C, Leclercq C, Ritter P, Ollivier JF, Shan N, Ziglio F, Feuerstein D. Exploring a New Systematic Route for Left Ventricular Pacing in Cardiac Resynchronization Therapy. Circ J. 2021 Feb 25;85(3):283-290. doi: 10.1253/circj.CJ-20-0266. Epub 2021 Jan 27.

    PMID: 33504741RESULT

Study Officials

  • Frédéric ANSELME, Pr

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2018

First Posted

November 21, 2018

Study Start

August 8, 2018

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

April 20, 2026

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)