CClinicalTrials.gg
TerminatedNCT05429645CRT3DUpdated Mar 30, 2025

Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation

An interventional study of setting up of the pace maker in Cardiac Anomaly, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment

Why this study was terminated
A new technique has rendered the study technique obsolete, making it inappropriate to continue the study due to lack of therapeutic interest.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium

Read the detailed description

As part of this study, to avoid surgery, the doctor will use a 3-dimensional (3D) guidance technique to position the heart probes in an optimal position during a new endovascular intervention.

02

Conditions studied

  • Cardiac Anomaly
03

In context

Heart Defects, Congenital

1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with indication for implantation of a classic multisite pacemaker;
  • New York Heart Association II/IV patient despite optimal medical treatment;
  • Patient with left ventricular ejection fraction ≤35%;
  • Patient with a widened QRS > 120ms;
  • Patient with at least one lateral coronary sinus vein visualized on angiography during the 1st procedure (if performed);
  • Patient with failure of resynchronization via the endovenous route due to difficulty in accessing the coronary sinus or instability in the coronary sinus;
  • Patient having been informed and having signed an informed consent form;
  • Patient able to understand the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), and to complete questionnaires.

Exclusion criteria

Exclusion Criteria:

  • Patient with resynchronization failure due to occlusion of the superior vena cava;
  • Patient with no usable lateral coronary sinus vein;
  • Patient with a life expectancy \< 3 months;
  • Patient wearing a vena cava filter;
  • Patient with active sepsis;
  • Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
  • Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
  • Patient not benefiting from a social security scheme.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    3-dimensional guidance technique

    3-dimensional (3D) guidance technique to position the heart probes in the setting up of a pace maker

    Procedure: setting up of the pace maker

Interventions

  • Proceduresetting up of the pace maker

    Setting up of a pace maker using a 3-dimensional (3D) guidance technique

06

What researchers measure

Primary outcomes

  1. Setting up with success of the Left Ventricular lead

    Feasibility of cardiac resynchronization under 3 dimension assistance in the event of primary implantation failure will be assessed by the proportion of patients for whom the Left Ventricular lead has been placed successfully with a pacemaker

    Time frame: during the time of the setting up of the pace maker

07

Study locations

1 site
  • Hôpital Privé Le Bois
    Lille, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05429645
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators
Euraxi Pharma
Responsible party
Sponsor
First posted
Jun 23, 2022
Start date
Jul 28, 2022
Primary completion
Jan 23, 2024
Completion
Jan 23, 2024
Last update
Mar 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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