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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02083016
Other study ID # PentaRay
Secondary ID
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
Health authority
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

Study Design


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.
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