Clinical trial NCT02083016: Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
Official title: Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Tachycardia
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Mapping and ablation times
timeFrame: During procedure.
Secondary outcomes:
measure: Scar area correlation with MRI.
timeFrame: Immediately after intervention.
measure: Radiofrequency delivery time.
timeFrame: During procedure.
measure: Reduction of residual electrograms with delayed component.
timeFrame: Immediately after intervention.
measure: Ventricular tachycardia inducibility after ablation.
timeFrame: Immediately after intervention.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Universitari
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Juan Acosta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hosptial Clínic de Barcelona
name: Diego Penela, MD
role: PRINCIPAL_INVESTIGATOR
References: