SMARTIS: SMART Identification of Ventricular Tachycardia Isthmus

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04852497
Collaborator
(none)
60
1
65
0.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ventricular tachycardia ablation

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
SMART Identification of Ventricular Tachycardia Isthmus
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Correlation between reference-less gradients identified by the SMARTIS software and the ventricular tachycardia isthmus [through study completion, an average of 1 year]

Secondary Outcome Measures

  1. 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]

  2. Ventricular tachycardia free survival according to the presence of unablated reference-less gradients after VT ablation [through study completion, an average of 1 year]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Nancy Vandoeuvre les nancy France 54500

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christian DE CHILLOU, Principal Investigator, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT04852497
Other Study ID Numbers:
  • 2018-110
First Posted:
Apr 21, 2021
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022