Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation

Phase 4

Completed

• Conditions: Ventricular Tachycardia
• Interventions: Device: Ablation guided by conventional mapping.; Device: Ablation guided by ultra-high density mapping with multielectrode catheter.

• Registration Number: NCT02083016
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Ultra-high density mapping with multielectrode catheter may improve slow conduction channels identification in ventricular tachycardia substrate ablation procedures compared to conventional point by point mapping.

This study compares the ability of both mapping catheters to detect slow conduction channels in areas of myocardial scar and their utility to assess substrate modification after ablation.

Detailed Description

This is a prospective, randomized controlled study. Twenty patients with sustained ventricular tachycardia and structurally abnormal ventricle(s) will be prospectively enrolled. In all patients a detailed pre and post-ablation electroanatomical mapping will be performed, and these maps will be merged with CT and/or MRI images. Patients will be randomly assigned to two groups. In Group A patients both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, target ablation sites will be guided by point by point map. In Group B patients, both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group target ablation sites will be guided by multielectrode contact mapping.

Slow conduction channels will be identified by color-coded voltage map adjustment of the lower and upper thresholds and also the presence of fractioned electrograms with the delayed component showing sequential orthodromic activation. The entrances of these channels will be the target of the ablation sites (scar dechanneling technique).

Study Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-11
• Study Start: 2014-04
• Primary Completion: 2015-12
• Study Completion: 2017-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with indication for ventricular tachycardia substrate ablation.

Exclusion Criteria

• Pregnant woman.
• Reduced expectancy of life (less than 12 months)
• Patient participating in another clinical study that investigates a drug or device
• Psychologically unstable patient or denies to give informed consent
• Any cause that contraindicate ablation procedure or antiarrhythmic drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Mapping	Ablation guided by conventional mapping.	Both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, ablation will be guided by conventional mapping.
Multielectrode mapping.	Ablation guided by ultra-high density mapping with multielectrode catheter.	Both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group ablation will be guided by multielectrode contact mapping.

Primary Outcome Measures

Name	Time	Method
Mapping and ablation times	During procedure.	Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).

Secondary Outcome Measures

Name	Time	Method
Scar area correlation with MRI.	Immediately after intervention.	To assess the correlation between the values of scar area obtained from both electroanatomical mapping systems and those resulting from the analysis of MRI.
Radiofrequency delivery time.	During procedure.
Reduction of residual electrograms with delayed component.	Immediately after intervention.	Reduction of residual electrograms with delayed component after ablation.
Ventricular tachycardia inducibility after ablation.	Immediately after intervention.

Trial Locations

Locations (1)

Hospital Clinic Universitari; 🇪🇸 Barcelona, Spain