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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02083016
Enrollment
20
Registered
2014-03-11
Start date
2014-04-30
Completion date
2017-01-31
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Tachycardia

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).

Interventions

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.

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mapping and ablation timesDuring procedure.Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).

Secondary

MeasureTime frameDescription
Ventricular tachycardia inducibility after ablation.Immediately after intervention.
Radiofrequency delivery time.During procedure.
Reduction of residual electrograms with delayed component.Immediately after intervention.Reduction of residual electrograms with delayed component after ablation.
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026