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

NCT03611465 | Unknown

• 1 other identifier: 2017-A01857-46
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Keywords

Sudden cardiac death; Electrophysiologic exploration; Myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

VT ablation group

OTHER

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

Other: Standard pace-mapping examination

pre implantation group

EXPERIMENTAL

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

Other: Pace-mapping

control group

EXPERIMENTAL

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

Interventions

Pace-mapping OTHER

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

control group; pre implantation group

Standard pace-mapping examination OTHER

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

VT ablation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

RECRUITING

Related 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. doi: 10.1016/j.hrthm.2013.10.042.

  PMID: 24513915 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular; Death, Sudden, Cardiac; Myocardial Infarction

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Central Study Contacts

Jean-Marc SELLAL

CONTACT

0033 3 83 15 32 56; jm.sellal@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist specialised in rhythmology

Model Details: There is no randomization. Patients are provided into 3 groups according to their pathology.

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: August 2, 2018
• Study Start: October 26, 2018
• Primary Completion: October 26, 2023
• Study Completion: April 26, 2024
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

FR (1)