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

C

Central Hospital, Nancy, France

Status

Enrolling

Conditions

Ventricular Tachycardia

Treatments

Other: Standard pace-mapping examination
Other: Pace-mapping

Study type

Interventional

Funder types

Other

Identifiers

NCT03611465
2017-A01857-46

Details and patient eligibility

About

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.

Full 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.

Enrollment

117 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

117 participants in 3 patient groups

VT ablation group
Other group
Description:
patients presenting history of myocardial infarction and ventricular tachycardia undergoing a VT ablation
Treatment:
Other: Standard pace-mapping examination
pre implantation group
Experimental group
Description:
patients presenting history of myocardial infarction but without history of ventricular tachycardia. Patients scheduled for a cardiac defibrillator implantation in primary prevention.
Treatment:
Other: Pace-mapping
control group
Experimental group
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.
Treatment:
Other: Pace-mapping

Trial contacts and locations

1

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Central trial contact

Jean-Marc SELLAL

Data sourced from clinicaltrials.gov

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