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Late Potentials and Ablation Index in Ventricular Tachycardia Ablation

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ClinicalTrials.gov Identifier: NCT03437408
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:
There is an increasing evidence regarding the efficacy of a substrate-based ablation approach to ventricular tachycardia (VT). This approach involves identifying regions of scar and also areas displaying late potentials and fractionated activity. Automated mapping systems are now available which may be able to generate high density maps displaying regions containing both late potentials and ventricular scar. Such an automated approach has not been validated. Furthermore, most patients presenting for VT ablation have pacing devices in situ. It is not known how the pacing modality affect the substrate maps generated for these procedures. Once an area felt to be important to ablate has been identified, the next key step is to perform effective ablation. An algorithm has now been made available (Ablation index - Biosense Webster Inc.,) which in preclinical studies is an effective predictor of radiofrequency lesion depth. This algorithm has been studied extensively in the atrium but not in the ventricle. This study would also seek to collect ablation index data during ablation to assess the algorithm during ventricular ablation.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Device: Mapping and ablation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Ventricular Substrate maps in patients undergoing ablation for VT - maps collected with automated tagging in different pacing modalities. Validation of collected substrate. Collection of impedance and ablation index data during ablation
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Influence of Ventricular Pacing on Automated Ventricular Substrate Mapping and Relationship Between Ablation Index and Impedance Drop in the Human Ventricle
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mapping and ablation
Automated Substrate maps with different pacing modes. Validation of collected substrate. Data collection during ablation
Device: Mapping and ablation
High density substrate map. Data collection during ablation




Primary Outcome Measures :
  1. Areas with ventricular tachycardia substrate [ Time Frame: Through study completion, an average of 1 year ]
    Quantification of late potential area and scar area with comparison between pacing modalities


Secondary Outcome Measures :
  1. Relationship between ablation index and impedance drop [ Time Frame: Through study completion, an average of 1 year ]
    Quantification of the relationship between ablation index and impedance drop during ablation.

  2. Relationship between Force Time Integral and impedance drop [ Time Frame: Through study completion, an average of 1 year ]
    Quantification of the relationship between Force Time Integral and impedance drop during ablation.

  3. Relationship between electrogram attenuation and impedance drop [ Time Frame: Through study completion, an average of 1 year ]
    Quantification of the relationship between electrogram attenuation and impedance drop during ablation.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ventricular Tachycardia; scheduled for ablation on clinical grounds; able/willing to consent to procedure/research protocol; no contraindication to clinical ablation; ≥18 years old

Exclusion Criteria:

  • Unable/unwilling to consent; contraindication to clinical ablation

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): NCT03437408


Contacts
Contact: Waqas Ullah, PhD 02380777222 ext 8128 waqas.ullah@uhs.nhs.uk

Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Biosense Webster, Inc.
Investigators
Principal Investigator: Waqas Ullah, PhD University Hospital Southampton NHS Foundation Trust

Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03437408     History of Changes
Other Study ID Numbers: RHM CAR0538
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Southampton NHS Foundation Trust:
Ventricular Tachycardia
Catheter Ablation
Late Potential
Ablation Index
Pacing

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes