Clinical Trials Directory

Trials / Completed

CompletedNCT02083016

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Hospital Clinic of Barcelona · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEAblation guided by conventional mapping.Substrate mapping and ablation of ventricular tachycardia.
DEVICEAblation guided by ultra-high density mapping with multielectrode catheter.Substrate mapping and ablation of ventricular tachycardia.

Timeline

Start date
2014-04-01
Primary completion
2015-12-01
Completion
2017-01-01
First posted
2014-03-11
Last updated
2017-02-27

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT02083016. Inclusion in this directory is not an endorsement.