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Status unknownNCT03611465ATLASUpdated Aug 9, 2022

Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts

An interventional study of Pace-mapping and Standard pace-mapping examination in Ventricular Tachycardia, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-09.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
117
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Aim of this study is to collect data from pace mapping performed in three groups of patients : patients presenting ventricular tachycardia and infarction history, patients presenting infarction history without presenting ventricular tachycardia, and in patients without structural heart disease.

Read the detailed description

Ventricular tachycardia (VT) represent an important problem in western countries. 350 000 deaths are attributable to ventricular arrhythmias in Europe every year. The gold standard treatment is to implant a cardiac defibrillator that will be able to stop arrhythmia by delivering pacing or internal shocks.

In order to avoid internal shocks, ablation techniques have been developed, consisting in placing catheters in the left ventricle, to induce the VT, and then to perform a mapping of its circuit. Once this circuit is clearly defined, ablation of the critical part of the circuit, so called VT isthmus can be performed, using a radiofrequency power. One of the limitations of this technique is that it requires VT induction during the procedure, and that the VT lasts long enough to enable its mapping.

Nancy University Hospital developed a technique using pace mapping to define the VT isthmus even when the VT is not sustained. The pace mapping technique enables to reveal conduction troubles in the studied ventricles, that correspond with the VT isthmus.

During this study, the investigators will collect pace-mapping data from ventricles of patient presenting infarction history and VT, from patients with infarction history without VT, and from patients without ventricular pathology.

02

Conditions studied

  • Ventricular Tachycardia

Keywords

  • Sudden cardiac death
  • Electrophysiologic exploration
  • Myocardial infarction
03

In context

Tachycardia

623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.

This study's planned enrollment of 117 is above the median of 64 across 379 interventional studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 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

  • Presenting one of these conditions :
  • patients undergoing a VT ablation and myocardial infarction history
  • patients with myocardial infarction history without VT history
  • patients without myocardial infarction history but undergoing an invasive procedure in left atrium (atrial fibrillation or accessory pathway ablation)

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • LVEF (left ventricular ejection fraction ) \<20 %
  • hemorrhagic stroke history
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
117 participants (estimated)

Study arms

  • Other
    VT ablation group

    patients presenting history of myocardial infarction and ventricular tachycardia undergoing a VT ablation

    Other: Standard pace-mapping examination

  • Experimental
    pre implantation group

    patients presenting history of myocardial infarction but without history of ventricular tachycardia. Patients scheduled for a cardiac defibrillator implantation in primary prevention.

    Other: Pace-mapping

  • Experimental
    control group

    patients without history of myocardial infarction and without history of ventricular tachycardia, undergoing an ablation in the left atrium for an atrial fibrillation or an accessory pathway ablation.

    Other: Pace-mapping

Interventions

  • OtherPace-mapping

    Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

  • OtherStandard pace-mapping examination

    Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

06

What researchers measure

Primary outcomes

  1. Complete electrophysiology datasets for each group

    Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during topo-stimulation. Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during pace-mapping. It will be considered complete if 100 measurement points have been acquired (pace-mapping and ECG), covering all 17 segments of the left ventricle.

    Time frame: the electrophysiological exploration is carried out the day after the patient's hospitalization and the datasets are generated just after removing the catheter from the patient, ie about 3 hours later the beginning of the exploration

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • de Chillou C, Groben L, Magnin-Poull I, Andronache M, MagdiAbbas M, Zhang N, Abdelaal A, Ammar S, Sellal JM, Schwartz J, Brembilla-Perrot B, Aliot E, Marchlinski FE. Localizing the critical isthmus of postinfarct ventricular tachycardia: the value of pace-mapping during sinus rhythm. Heart Rhythm. 2014 Feb;11(2):175-81. doi: 10.1016/j.hrthm.2013.10.042. PubMed 24513915 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03611465
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Dr Jean-Marc SELLAL (Cardiologist specialised in rhythmology, Central Hospital, Nancy, France) — Principal investigator
First posted
Aug 2, 2018
Start date
Oct 26, 2018
Primary completion
Oct 26, 2023 (estimated)
Completion
Apr 26, 2024 (estimated)
Last update
Aug 9, 2022

Study contacts

Jean-Marc SELLAL
Contact
jm.sellal@chru-nancy.fr
0033 3 83 15 32 56

Oversight

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

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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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