At a glance

ClinicalIndex Comparison Record

N/ACompleted· 101 enrolled

Drug / intervention

CathVision Cube® systemdevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05043883

NCT05043883N/ACompleted

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Automated Assessment of Pulmonary Vein Isolation (PVI) Using a Novel EP Recording System (CathVision Cube® System)

CathVision ApS·interventional·Posted Sep 14, 2021·Updated Aug 9, 2024

In Brief

A clinical study evaluating CathVision Cube® system for Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation. Completed, enrolled 101 participants across 4 sites in 2 countries.

Detailed Summary

A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsParoxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

CountriesBelgium, France

CollaboratorsAKRN Scientific Consulting, S.L.

Timeline

N/ACompletedFinished

20222023202420252026

First PostedSep 2021

Enrollment StartSep 2021

Primary CompletionJun 2022

TodayJul 2026

First PostedSep 14, 2021

Enrollment StartSep 15, 2021

Primary CompletionJun 22, 2022

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 4.8 years ago

Interventions

CathVision Cube® systemdevice

Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the commercial (bearing CE mark) EP recording systems LabSystem Pro, Boston Scientific EP, or EP-Tracer, Schwarzer Cardiotek. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the PVI Analyzer will be performed offline and retrospectively.