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

Ventricular Tachycardia Clinical Trial

— ATLAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03611465
• Other study ID #: 2017-A01857-46
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2018
• Est. completion date: April 26, 2024

Study information

• Verified date: August 2022
• Source: Central Hospital, Nancy, France
• Contact: Jean-Marc SELLAL
• Phone: 0033 3 83 15 32 56
• Email: jm.sellal[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: April 26, 2024
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Other:
• Pace-mapping
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.
• Standard pace-mapping examination
Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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