ClinicalTrials.gg
Status unknownNCT03453645Updated Jul 11, 2018

Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation

An observational study in Ventricular Tachycardia, sponsored by University Hospital, Toulouse. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-11.

Sponsored by University Hospital, Toulouse · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.

Read the detailed description

Sudden cardiac death is a frequent cause of cardiovascular mortality. Numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. Development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.

Rhythmic risk assessment criterions have never been studied in relation with ventricular tachycardia ablation. The purpose of this study is to explore the modifications of these criterions after ventricular tachycardia ablation.

02

Conditions studied

  • Ventricular Tachycardia

Keywords

  • ablation
  • sudden death
  • signal averaged ECG
  • T wave alternans
  • heart rate variability
03

In context

Tachycardia, Ventricular

451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.

This study's planned enrollment of 30 is below the median of 167 across 147 observational studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 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
Sampling method
Non-probability sample

Study population

people wich an Ventricular Tachycardia Ablation necessary and programed

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing ventricular tachycardia,
  • patients with ischemic cardiomyopathy according to European Society of Cardiology Guidelines,
  • patients with implanted cardiac defibrillator.

Exclusion criteria

Exclusion Criteria:

  • to stress test,
  • permanent atrial fibrillation,
  • permanent ventricular pacing,
  • left bundle block.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • Procedureventricular tachycardia ablation

    The usual organization of hospitalization of the patients addressed for ventricular tachycardia ablation and his follow-up are not modified by the protocol. .

06

What researchers measure

Primary outcomes

  1. measure assessing change before and after Ventricular Tachycardia Ablation of the non-invasive parameters analysis of the rhythmic risk before and after Ventricular Tachycardia Ablation

    non invasive parameters analysis of the rhythmic risk will be evaluated by the evaluation of the T wave alternans

    Time frame: 10 minutes and 60 minutes after the Ventricular Tachycardia Ablation

Secondary outcomes

  1. Assessing the correlations of the modifications of the risk criterion after ablation with the recurrences of arrhythmias at one year follow-up

    the recurrences of arrhythmias will be evaluated . There will be assessed by the informations reveled by the Implantable automatic defibrillator

    Time frame: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation

  2. Study of the correlation between the modifications of non-invasive parameters analysis of the rhythmic risk and the success of the ablation procedure

    Success of the ablation procedure is defined by the absence of inducible Ventricular Tachycardia at the end of the procedure.

    Time frame: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Toulouse
    Toulouse, 31000, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2017 (actual). Primary completion is estimated for Sep 2018, 12 months after the start.

Of 69 observational studies under Tachycardia, Ventricular, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 108. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2017
First posted
Mar 5, 2018
StartActual
Sep 9, 2017
Primary completionEst.
Sep 2018
CompletionEst.
Feb 2019
Last update
Jul 11, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03453645
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Sep 9, 2017
Primary completion
Sep 2018 (estimated)
Completion
Feb 2019 (estimated)
Last update
Jul 11, 2018

Study contacts

Philippe MAURY, MD
Contact
maury.p@chu-toulouse.fr
05 61 32 31 00
Isabelle OLIVIER, PhD
Contact
olivier.i@chu-toulouse.fr
05 61 77 70 51 ext. +33
Philippe MAURY, MD
principal investigator · University Hospital of Toulouse

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 status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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