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Dispersion Stability

NCT04945746 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-09-19

No results posted yet for this study

Summary

To assess the acute efficacy of ablation of the most stable VX1 areas (levels 2 and 3) in terms of the rate of acute AF termination.

Identify the spatial distribution of dispersion stability levels based on VX1. Document the rate of adverse events. To assess the long-term efficacy of ablation of the most stable VX1 areas in terms of the absence of documented arrhythmias during a 12-month follow-up.

Conditions

Interventions

PROCEDURE

AF ablation

AF ablation using the Volta Medical VX1 CE marked software and a new criteria to establish a priority of the dispersed zones according to the stability of the core algorithm's response (thanks to the new software module under study named "stability").

Sponsors & Collaborators

  • Hospital St. Joseph, Marseille, France

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2023-10-28
Completion
2025-01-28

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 NCT04945746 on ClinicalTrials.gov