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

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ClinicalTrials.gov Identifier: NCT03611465
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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 structurtal heart disease.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Other: Pace-mapping Other: Standard pace-mapping examination Not Applicable

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 pacemapping data from ventricles of patient presenting infarction history and VT, from patients with infarction history without VT, and from patients without ventricular pathology.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There is no randomization. Patients are provided into 3 groups according to their pathology.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 5, 2020
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
VT ablation group
patients presenting history of myocardial infarction and ventricular tachycardia undergoing a VT ablation
Other: Standard pace-mapping examination
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

Experimental: pre implantation group
patients presenting history of myocardial infarction but without history of ventricular tachycardia. Patients schedulded for a cardiac defibrillator implantation in primary prevention.
Other: Pace-mapping
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

Experimental: control group
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.
Other: Pace-mapping
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.




Primary Outcome Measures :
  1. Complete electrophysiology datasets for each group [ 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 ]

    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 topostimulation.

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 inleft atrium (atrial fibrillation or accessory pathway ablation)

Exclusion Criteria:

  • pregnancy
  • LVEF<20 %
  • hemorragic stroke history

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): NCT03611465


Contacts
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Contact: Jean-Marc SELLAL 0033 3 83 15 32 56 jm.sellal@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France

Publications:
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03611465     History of Changes
Other Study ID Numbers: 2017-A01857-46
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: September 2017

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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 Central Hospital, Nancy, France:
Sudden cardiac death
Electrophisiologic exploration
Myocardial infarction
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes