SMART Identification of Ventricular Tachycardia Isthmus

Ventricular Tachycardia Clinical Trial

— SMARTIS  

Official title:

SMART Identification of Ventricular Tachycardia Isthmus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852497
• Other study ID #: 2018-110
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Context :

Ventricular tachycardia (VT) are serious heart rhythm disorders which can lead to sudden death. A curative treatment for these abnormalities in the cardiac electrical conduction system is possible through an interventional electrophysiology procedure. A catheter is inserted, generally via a femoral access, and is introduced in the heart ventricles in order to collect various 3D electro-anatomical maps.

The pace-mapping technique developed in Nancy (de Chillou et al, Heart Rhythm 2014) allows the reentrant circuit underlying the VT to be identified, as well as a definition of the target zones to be ablated, using radiofrequency energy with the catheter. The pace-mapping technique consists of stimulating the ventricle from various sites within its internal surface, in order to generate different activation pathways of the myocardium. When an activation pathway is similar to the VT pathway, this means that the stimulation site is located near the pathologic zone to be ablated. The surface electrocardiogram (ECG) is used to compare activation pathways. A 3D correlation ma is then generated: the zones with high correlation (>90%) indicated the exit of the reentrant circuit, while rapid transition zones (several %/mm) indicate the entrance of the VT circuit. The pace-mapping technique has several limitations: (i) it requires an ECG recording of the clinical VT of the patient (spontaneous or induced at the beginning of the procedure), however it is not always possible to induce it; (ii) sometimes several VT circuits may be present, rendering the procedure of identification and ablation non-exhaustive.

The aim of this study is to analyze retrospectively electroanatomical data collected during the intervention, in order to develop a new method for identifying target zones to be ablated, and to compare the results with the conventionally used method.

Hypothesis :

The investigators hypothesize that alternative methods to analyze electroanatomical data (surface ECG and spatial coordinates of the pacing sites) could provide information equivalent to conventional methods (e.g. VT correlation map, VT activation maps etc…) without the need for a reference recording of the clinical VT of the patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ventricular tachycardia ablation between October 2014 and April 2021

• Patient for whom electroanatomical data are available.

• Ischemic cardiomyopathy / previous myocardial infarction

• At least 30 points of pace-mapping during the VT procedure

Exclusion Criteria:

• Incomplete data

• Poor quality ECG recordings

• Absence of ventricular tachycardia isthmus identified during the procedure

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemic Cardiomyopathy
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• Ventricular tachycardia ablation
patients having undergone ventricular tachycardia radiofrequency ablation using of pace mapping strategy to identify the critical isthmus

Locations

Country	Name	City	State
France	University Hospital of Nancy	Vandoeuvre les nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between reference-less gradients identified by the SMARTIS software and the ventricular tachycardia isthmus		through study completion, an average of 1 year
Secondary	Electrophysiological features associated with reference-less gradients identified by the SMARTIS software and the ventricular tachycardia isthmus		through study completion, an average of 1 year
Secondary	Ventricular tachycardia free survival according to the presence of unablated reference-less gradients after VT ablation		through study completion, an average of 1 year
Secondary	Correlation between reference-less gradients identified by the SMARTIS software and myocardial scar as assessed by cardiac MRI late gadolinium enhancement		through study completion, an average of 1 year