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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03453645
Other study ID # RC31/17/0066
Secondary ID 2017-A00582-51
Status Recruiting
Phase
First received
Last updated
Start date September 9, 2017
Est. completion date February 2019

Study information

Verified date July 2018
Source University Hospital, Toulouse
Contact Philippe MAURY, MD
Phone 05 61 32 31 00
Email maury.p@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing ventricular tachycardia,

- patients with ischemic cardiomyopathy according to European Society of Cardiology Guidelines,

- patients with implanted cardiac defibrillator.

Exclusion Criteria:

- Contra-indication to stress test,

- permanent atrial fibrillation,

- permanent ventricular pacing,

- left bundle block.

Study Design


Intervention

Procedure:
ventricular 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. .

Locations

Country Name City State
France University Hospital of Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation
Secondary 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. 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation
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