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

NCT ID: NCT02083016

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2017-01-31

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).

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Mapping

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.

Group Type: OTHER

Ablation guided by conventional mapping.

Intervention Type: DEVICE

Substrate mapping and ablation of ventricular tachycardia.

Multielectrode 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.

Group Type: OTHER

Ablation guided by ultra-high density mapping with multielectrode catheter.

Intervention Type: DEVICE

Substrate mapping and ablation of ventricular tachycardia.

Interventions

Ablation guided by conventional mapping.

Substrate mapping and ablation of ventricular tachycardia.

Intervention Type: DEVICE

Ablation guided by ultra-high density mapping with multielectrode catheter.

Substrate mapping and ablation of ventricular tachycardia.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Antonio Berruezo, MD, PhD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Acosta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Diego Penela, MD

Role: PRINCIPAL_INVESTIGATOR

Hosptial Clínic de Barcelona

Locations

Hospital Clinic Universitari

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

PentaRay

Identifier Type: -

Identifier Source: org_study_id