NCT03453645

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

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, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

July 27, 2017

Last Update Submit

July 10, 2018

Conditions

Keywords

ablationsudden deathsignal averaged ECGT wave alternansheart rate variability

Outcome Measures

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

    10 minutes and 60 minutes after the Ventricular Tachycardia Ablation

Secondary Outcomes (2)

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

    3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation

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

    3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people wich an Ventricular Tachycardia Ablation necessary and programed

You may qualify if:

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

You may not qualify if:

  • Contra-indication to stress test,
  • permanent atrial fibrillation,
  • permanent ventricular pacing,
  • left bundle block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Tachycardia, VentricularDeath, Sudden

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsDeath

Study Officials

  • Philippe MAURY, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe MAURY, MD

CONTACT

Isabelle OLIVIER, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

March 5, 2018

Study Start

September 9, 2017

Primary Completion

September 1, 2018

Study Completion

February 1, 2019

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations