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

NCT ID: NCT03611465

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-26

Study Completion Date

2024-04-26

Brief Summary

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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

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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.

Conditions

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Ventricular Tachycardia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

There is no randomization. Patients are provided into 3 groups according to their pathology.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VT ablation group

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

Group Type OTHER

Standard pace-mapping examination

Intervention Type OTHER

Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

pre implantation group

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

Group Type EXPERIMENTAL

Pace-mapping

Intervention Type OTHER

Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

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.

Group Type EXPERIMENTAL

Pace-mapping

Intervention Type OTHER

Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

Interventions

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Pace-mapping

Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

Intervention Type OTHER

Standard pace-mapping examination

Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Dr Jean-Marc SELLAL

Cardiologist specialised in rhythmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHRU de Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Marc SELLAL

Role: CONTACT

0033 3 83 15 32 56

Facility Contacts

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Claire DESSALE

Role: primary

+33383157823

References

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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.

Reference Type BACKGROUND
PMID: 24513915 (View on PubMed)

Other Identifiers

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2017-A01857-46

Identifier Type: -

Identifier Source: org_study_id

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