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Validation of the Advisor HD Grid Mapping Catheter in Atrial Fibrillation Ablation

NCT04850508 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2022-11-15

No results posted yet for this study

Summary

The primary study concept is to evaluate the superiority of the HD Grid high-density mapping catheter over the current standard 20-pole circular mapping catheter in pulmonary vein isolation (PVI) in atrial fibrillation. A minimum of 20 evaluable subjects with symptomatic atrial fibrillation scheduled for a clinically indicated first PVI ablation will be included.

Conditions

Interventions

DEVICE

Mapping and ablation with the Advisor HD Grid catheter

After confirmation of isolation of the first pair of veins, the CMC-20 catheter will be exchanged for the HD Grid catheter. Using the HD Grid catheter, a new map of the left atrium will be made using the high-density settings. Together with the left atrium, the pulmonary veins will be mapped again in search of electro-anatomical gaps. Gaps are defined as a local area from the ablation line reaching inwards the pulmonary vein which still shows activation or fractionated potentials in line with atrial activation whilst pacing remote in the left atrium. The After mapping the first ablation side, the CMC-20 will be reinserted to repeat the protocol for the remaining pair of veins 30 minutes after ablation ended for that side. If gaps have been found, HD Grid guided additional ablation must be performed to achieve isolation in that vein until isolation is reconfirmed.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Vikas P Kuriachan, MD · Libin Cardiovascular Institute of Alberta, University of Calgary

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-27
Primary Completion
2022-11-01
Completion
2022-11-01

Countries

  • Canada

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 NCT04850508 on ClinicalTrials.gov