Overview

This trial is active, not recruiting.

Condition ventricular tachycardia
Treatments ablation guided by conventional mapping., ablation guided by ultra-high density mapping with multielectrode catheter.
Phase phase 4
Sponsor Hospital Clinic of Barcelona
Start date April 2014
End date December 2015
Trial size 20 participants
Trial identifier NCT02083016, PentaRay

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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.
ablation guided by conventional mapping.
Substrate mapping and ablation of ventricular tachycardia.
(Other)
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.
ablation guided by ultra-high density mapping with multielectrode catheter.
Substrate mapping and ablation of ventricular tachycardia.

Primary Outcomes

Measure
Mapping and ablation times
time frame: During procedure.

Secondary Outcomes

Measure
Scar area correlation with MRI.
time frame: Immediately after intervention.
Radiofrequency delivery time.
time frame: During procedure.
Reduction of residual electrograms with delayed component.
time frame: Immediately after intervention.
Ventricular tachycardia inducibility after ablation.
time frame: Immediately after intervention.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
Principal investigator Juan Acosta, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.