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AutoMatic disPERsion Tagging Function Preliminary Evaluation

NCT05362656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-22

No results posted yet for this study

Summary

Interventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of VX1+ medical device, aiming to verify that VX1+ in bidirectional configuration with auto-tagging function is both ergonomic and reliable for dispersed electrograms detection and automatic tagging on 3D-map in real-time.

Conditions

Interventions

DEVICE

VX1+ dispersion mapping

Careful biatrial high density dispersion mapping is performed as the first step of the procedure. Operators map each region of both atria carefully by moving the mapping catheter slowly. If VX1+ application detects dispersion regions, the corresponding dipoles location will be automatically tagged on the 3D-map. Accuracy and relevance of dispersion regions should be confirmed by the operator by checking EGMs visually.

Sponsors & Collaborators

  • Volta Medical

    lead INDUSTRY

Principal Investigators

  • Julien SEITZ, MD · Hôpital Saint-Joseph Marseille

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-29
Primary Completion
2022-12-09
Completion
2022-12-09

Countries

  • France

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 NCT05362656 on ClinicalTrials.gov