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INtra-procedural ultraSound Imaging During Pulmonary Veins Isolation

NCT03372798 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2024-04-18

Study results available
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Summary

One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information about the left atrial (LA) wall thickness and about its acute changes during energy delivery for ablation. This makes difficult to predict the achievement of transmural lesions, to identify the possible causes of ablation failure and also to avoid the occurrence of perforation and/or other collateral damage.

Computed tomography (CT) is a reliable technique for measurement of the LA wall thickness but it cannot be used during the ablation procedure and its extensive use is limited by the need of ionizing radiation. Preliminary data from animal studies support the accuracy of real-time ultrasound imaging modalities such as intracardiac echocardiography (ICE) or Intravascular Ultrasound (IVUS) imaging for measurement of LA wall thickness and monitoring of its acute changes related to catheter ablation.

The pilot study INSIDE PVs has been primarily designed to evaluate the feasibility and accuracy of intravascular imaging techniques for real-time imaging of the LA wall thickness during AF ablation.

Conditions

Interventions

PROCEDURE

ICE/IVUS imaging during atrial fibrillation ablation

Intravascular ultrasound imaging of the left atrial wall thickness with ICE/IVUS during atrial fibrillation ablation

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Tim Betts, MD · Oxford University Hospitals NHS Trust

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372798 on ClinicalTrials.gov