Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
Primary Purpose
Ventricular Tachycardia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Ablation guided by conventional mapping.
Ablation guided by ultra-high density mapping with multielectrode catheter.
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia
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
Sites / Locations
- Hospital Clinic Universitari
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Conventional Mapping
Multielectrode mapping.
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Mapping and ablation times
Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).
Secondary Outcome Measures
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.
Radiofrequency delivery time.
Reduction of residual electrograms with delayed component.
Reduction of residual electrograms with delayed component after ablation.
Ventricular tachycardia inducibility after ablation.
Full Information
NCT ID
NCT02083016
First Posted
March 5, 2014
Last Updated
February 24, 2017
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT02083016
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Mapping
Arm Type
Other
Arm Description
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.
Arm Title
Multielectrode mapping.
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ablation guided by conventional mapping.
Intervention Description
Substrate mapping and ablation of ventricular tachycardia.
Intervention Type
Device
Intervention Name(s)
Ablation guided by ultra-high density mapping with multielectrode catheter.
Intervention Description
Substrate mapping and ablation of ventricular tachycardia.
Primary Outcome Measure Information:
Title
Mapping and ablation times
Description
Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).
Time Frame
During procedure.
Secondary Outcome Measure Information:
Title
Scar area correlation with MRI.
Description
To assess the correlation between the values of scar area obtained from both electroanatomical mapping systems and those resulting from the analysis of MRI.
Time Frame
Immediately after intervention.
Title
Radiofrequency delivery time.
Time Frame
During procedure.
Title
Reduction of residual electrograms with delayed component.
Description
Reduction of residual electrograms with delayed component after ablation.
Time Frame
Immediately after intervention.
Title
Ventricular tachycardia inducibility after ablation.
Time Frame
Immediately after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Acosta, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diego Penela, MD
Organizational Affiliation
Hosptial Clínic de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic Universitari
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
We'll reach out to this number within 24 hrs