Late Potentials and Ablation Index in Ventricular Tachycardia Ablation

NCT03437408 | Completed

• 1 other identifier: RHM CAR0538
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Keywords

Ventricular Tachycardia; Catheter Ablation; Late Potential; Ablation Index; Pacing

Outcome Measures

Primary Outcomes (1)

• Areas with ventricular tachycardia substrate

  Quantification of late potential area and scar area with comparison between pacing modalities

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Relationship between ablation index and impedance drop

  Through study completion, an average of 1 year

• Relationship between Force Time Integral and impedance drop

  Through study completion, an average of 1 year

• Relationship between electrogram attenuation and impedance drop

  Through study completion, an average of 1 year

Study Arms (1)

Mapping and ablation

EXPERIMENTAL

Automated Substrate maps with different pacing modes. Validation of collected substrate. Data collection during ablation

Device: Mapping and ablation

Interventions

Mapping and ablation DEVICE

High density substrate map. Data collection during ablation

Mapping and ablation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable/unwilling to consent; contraindication to clinical ablation

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (1)

• Bates AP, Paisey J, Yue A, Banks P, Roberts PR, Ullah W. Radiofrequency Ablation of the Diseased Human Left Ventricle: Biophysical and Electrogram-Based Analysis. JACC Clin Electrophysiol. 2023 Mar;9(3):330-340. doi: 10.1016/j.jacep.2022.10.001. Epub 2022 Oct 10.

  PMID: 36371330 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Waqas Ullah, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 19, 2018
• Study Start: June 26, 2019
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)