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

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ClinicalTrials.gov Identifier: NCT02083016
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Antonio Berruezo, MD, PhD, Hospital Clinic of Barcelona

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.


Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Device: Ablation guided by conventional mapping. Device: Ablation guided by ultra-high density mapping with multielectrode catheter. Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Mapping and ablation times [ Time Frame: During procedure. ]
    Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).


Secondary Outcome Measures :
  1. Scar area correlation with MRI. [ Time Frame: Immediately after intervention. ]
    To assess the correlation between the values of scar area obtained from both electroanatomical mapping systems and those resulting from the analysis of MRI.

  2. Radiofrequency delivery time. [ Time Frame: During procedure. ]
  3. Reduction of residual electrograms with delayed component. [ Time Frame: Immediately after intervention. ]
    Reduction of residual electrograms with delayed component after ablation.

  4. Ventricular tachycardia inducibility after ablation. [ Time Frame: Immediately after intervention. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083016


Locations
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Spain
Hospital Clinic Universitari
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Juan Acosta, MD Hospital Clínic de Barcelona
Principal Investigator: Diego Penela, MD Hosptial Clínic de Barcelona

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Responsible Party: Antonio Berruezo, MD, PhD, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02083016     History of Changes
Other Study ID Numbers: PentaRay
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes