A Phase 4 interventional study of Ablation guided by conventional mapping. and Ablation guided by ultra-high density mapping with multielectrode catheter. in Ventricular Tachycardia, sponsored by Hospital Clinic of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-27.
Sponsored by Hospital Clinic of Barcelona · Phase 4, Interventional, and Treatment
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.
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).
623 studies on the registry are indexed under Tachycardia; 81 are open to participants now.
This study's planned enrollment of 20 is below the median of 64 across 379 interventional studies indexed under Tachycardia.
Browse Tachycardia studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Ablation guided by conventional mapping.
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.
Device: Ablation guided by ultra-high density mapping with multielectrode catheter.
Substrate mapping and ablation of ventricular tachycardia.
Substrate mapping and ablation of ventricular tachycardia.
Mapping and ablation times
Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).
Time frame: During procedure.
Scar area correlation with MRI.
To assess the correlation between the values of scar area obtained from both electroanatomical mapping systems and those resulting from the analysis of MRI.
Time frame: Immediately after intervention.
Radiofrequency delivery time.
Time frame: During procedure.
Reduction of residual electrograms with delayed component.
Reduction of residual electrograms with delayed component after ablation.
Time frame: Immediately after intervention.
Ventricular tachycardia inducibility after ablation.
Time frame: Immediately after intervention.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona