Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation

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.

Study Overview

• Status: Unknown
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Philippe MAURY, MD; Phone Number: 05 61 32 31 00; Email: maury.p@chu-toulouse.fr
• Study Contact Backup: Name: Isabelle OLIVIER, PhD; Phone Number: +33 05 61 77 70 51; Email: olivier.i@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • University Hospital of Toulouse
    • Contact: Philippe MAURY, MD; Phone Number: 05 61 32 31 00; Email: maury.p@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

people wich an Ventricular Tachycardia Ablation necessary and programed

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Philippe Maury, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2017
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): February 1, 2019

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (ACTUAL): March 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: ablation; heart rate variability; sudden death; signal averaged ECG; T wave alternans
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: RC31/17/0066; 2017-A00582-51 (OTHER: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No