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

NCT02083016 | Completed Phase 4

• 1 other identifier: PentaRay
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Mapping and ablation times

  Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).

  During procedure.

Secondary Outcomes (4)

• Scar area correlation with MRI.

  Immediately after intervention.

• Radiofrequency delivery time.

  During procedure.

• Reduction of residual electrograms with delayed component.

  Immediately after intervention.

• Ventricular tachycardia inducibility after ablation.

  Immediately after intervention.

Study Arms (2)

Conventional Mapping

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.

Device: Ablation guided by conventional mapping.

Multielectrode mapping.

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.

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

Interventions

Ablation guided by conventional mapping. DEVICE

Substrate mapping and ablation of ventricular tachycardia.

Conventional Mapping

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

Substrate mapping and ablation of ventricular tachycardia.

Multielectrode mapping.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with indication for ventricular tachycardia substrate ablation.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic Universitari

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Acosta, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Diego Penela, MD

  Hosptial Clínic de Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 11, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02

Locations

ES (1)