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Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation

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ClinicalTrials.gov Identifier: NCT03453645
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment
Ventricular Tachycardia Procedure: ventricular tachycardia ablation

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
Actual Study Start Date : September 9, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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. .


Primary Outcome Measures :
  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 [ Time Frame: 10 minutes and 60 minutes after the Ventricular Tachycardia Ablation ]
    non invasive parameters analysis of the rhythmic risk will be evaluated by the evaluation of the T wave alternans


Secondary Outcome Measures :
  1. Assessing the correlations of the modifications of the risk criterion after ablation with the recurrences of arrhythmias at one year follow-up [ Time Frame: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation ]
    the recurrences of arrhythmias will be evaluated . There will be assessed by the informations reveled by the Implantable automatic defibrillator

  2. Study of the correlation between the modifications of non-invasive parameters analysis of the rhythmic risk and the success of the ablation procedure [ Time Frame: 3 months, 6 months and 12 months after the Ventricular Tachycardia Ablation ]
    Success of the ablation procedure is defined by the absence of inducible Ventricular Tachycardia at the end of the procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
people wich an Ventricular Tachycardia Ablation necessary and programed
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453645


Contacts
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Contact: Philippe MAURY, MD 05 61 32 31 00 maury.p@chu-toulouse.fr
Contact: Isabelle OLIVIER, PhD 05 61 77 70 51 ext +33 olivier.i@chu-toulouse.fr

Locations
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France
University Hospital of Toulouse Recruiting
Toulouse, France, 31000
Contact: Philippe MAURY, MD    05 61 32 31 00    maury.p@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Philippe MAURY, MD University Hospital of Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03453645     History of Changes
Other Study ID Numbers: RC31/17/0066
2017-A00582-51 ( Other Identifier: ID-RCB )
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
ablation
sudden death
signal averaged ECG
T wave alternans
heart rate variability
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes