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

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083016
• Other study ID #: PentaRay
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2014
• Last updated: February 24, 2017
• Start date: April 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Ablation guided by conventional mapping.
Substrate mapping and ablation of ventricular tachycardia.
• Ablation guided by ultra-high density mapping with multielectrode catheter.
Substrate mapping and ablation of ventricular tachycardia.

Locations

Country	Name	City	State
Spain	Hospital Clinic Universitari	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mapping and ablation times	Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).	During procedure.
Secondary	Scar area correlation with MRI.	To assess the correlation between the values of scar area obtained from both electroanatomical mapping systems and those resulting from the analysis of MRI.	Immediately after intervention.
Secondary	Radiofrequency delivery time.		During procedure.
Secondary	Reduction of residual electrograms with delayed component.	Reduction of residual electrograms with delayed component after ablation.	Immediately after intervention.
Secondary	Ventricular tachycardia inducibility after ablation.		Immediately after intervention.