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Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts (ATLAS)

Primary Purpose

Ventricular Tachycardia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pace-mapping
Standard pace-mapping examination
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventricular Tachycardia focused on measuring Sudden cardiac death, Electrophysiologic exploration, Myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presenting one of these conditions :
  • patients undergoing a VT ablation and myocardial infarction history
  • patients with myocardial infarction history without VT history
  • patients without myocardial infarction history but undergoing an invasive procedure in left atrium (atrial fibrillation or accessory pathway ablation)

Exclusion Criteria:

  • pregnancy
  • LVEF (left ventricular ejection fraction ) <20 %
  • hemorrhagic stroke history

Sites / Locations

  • CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

VT ablation group

pre implantation group

control group

Arm Description

patients presenting history of myocardial infarction and ventricular tachycardia undergoing a VT ablation

patients presenting history of myocardial infarction but without history of ventricular tachycardia. Patients scheduled for a cardiac defibrillator implantation in primary prevention.

patients without history of myocardial infarction and without history of ventricular tachycardia, undergoing an ablation in the left atrium for an atrial fibrillation or an accessory pathway ablation.

Outcomes

Primary Outcome Measures

Complete electrophysiology datasets for each group
Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during topo-stimulation. Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during pace-mapping. It will be considered complete if 100 measurement points have been acquired (pace-mapping and ECG), covering all 17 segments of the left ventricle.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2018
Last Updated
August 5, 2022
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03611465
Brief Title
Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts
Acronym
ATLAS
Official Title
Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2018 (Actual)
Primary Completion Date
October 26, 2023 (Anticipated)
Study Completion Date
April 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim of this study is to collect data from pace mapping performed in three groups of patients : patients presenting ventricular tachycardia and infarction history, patients presenting infarction history without presenting ventricular tachycardia, and in patients without structural heart disease.
Detailed Description
Ventricular tachycardia (VT) represent an important problem in western countries. 350 000 deaths are attributable to ventricular arrhythmias in Europe every year. The gold standard treatment is to implant a cardiac defibrillator that will be able to stop arrhythmia by delivering pacing or internal shocks. In order to avoid internal shocks, ablation techniques have been developed, consisting in placing catheters in the left ventricle, to induce the VT, and then to perform a mapping of its circuit. Once this circuit is clearly defined, ablation of the critical part of the circuit, so called VT isthmus can be performed, using a radiofrequency power. One of the limitations of this technique is that it requires VT induction during the procedure, and that the VT lasts long enough to enable its mapping. Nancy University Hospital developed a technique using pace mapping to define the VT isthmus even when the VT is not sustained. The pace mapping technique enables to reveal conduction troubles in the studied ventricles, that correspond with the VT isthmus. During this study, the investigators will collect pace-mapping data from ventricles of patient presenting infarction history and VT, from patients with infarction history without VT, and from patients without ventricular pathology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Sudden cardiac death, Electrophysiologic exploration, Myocardial infarction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There is no randomization. Patients are provided into 3 groups according to their pathology.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VT ablation group
Arm Type
Other
Arm Description
patients presenting history of myocardial infarction and ventricular tachycardia undergoing a VT ablation
Arm Title
pre implantation group
Arm Type
Experimental
Arm Description
patients presenting history of myocardial infarction but without history of ventricular tachycardia. Patients scheduled for a cardiac defibrillator implantation in primary prevention.
Arm Title
control group
Arm Type
Experimental
Arm Description
patients without history of myocardial infarction and without history of ventricular tachycardia, undergoing an ablation in the left atrium for an atrial fibrillation or an accessory pathway ablation.
Intervention Type
Other
Intervention Name(s)
Pace-mapping
Intervention Description
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.
Intervention Type
Other
Intervention Name(s)
Standard pace-mapping examination
Intervention Description
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.
Primary Outcome Measure Information:
Title
Complete electrophysiology datasets for each group
Description
Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during topo-stimulation. Collection of all complete electrophysiology datasets for each group. A data set consists of the electro-anatomical data generated by the Carto system and ECG data collected during pace-mapping. It will be considered complete if 100 measurement points have been acquired (pace-mapping and ECG), covering all 17 segments of the left ventricle.
Time Frame
the electrophysiological exploration is carried out the day after the patient's hospitalization and the datasets are generated just after removing the catheter from the patient, ie about 3 hours later the beginning of the exploration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting one of these conditions : patients undergoing a VT ablation and myocardial infarction history patients with myocardial infarction history without VT history patients without myocardial infarction history but undergoing an invasive procedure in left atrium (atrial fibrillation or accessory pathway ablation) Exclusion Criteria: pregnancy LVEF (left ventricular ejection fraction ) <20 % hemorrhagic stroke history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc SELLAL
Phone
0033 3 83 15 32 56
Email
jm.sellal@chru-nancy.fr
Facility Information:
Facility Name
CHRU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire DESSALE
Phone
+33383157823
Email
cic-it-nancy@chru-nancy.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
24513915
Citation
de Chillou C, Groben L, Magnin-Poull I, Andronache M, MagdiAbbas M, Zhang N, Abdelaal A, Ammar S, Sellal JM, Schwartz J, Brembilla-Perrot B, Aliot E, Marchlinski FE. Localizing the critical isthmus of postinfarct ventricular tachycardia: the value of pace-mapping during sinus rhythm. Heart Rhythm. 2014 Feb;11(2):175-81. doi: 10.1016/j.hrthm.2013.10.042.
Results Reference
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Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts

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