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An Evaluation of the Safety and Performance of the CathVision Cube® System

NCT05114382 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-02-01

No results posted yet for this study

Summary

The primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

Conditions

  • Cardiac Arrhythmia

Interventions

PROCEDURE

EP Procedure

Intracardiac signals will be passively recorded using CathVision Cube® System in parallel with the commercial (CE marked) EP recording system during a scheduled electrophysiology procedure

Sponsors & Collaborators

  • TRIQ GROUP Wherry & Klaffke GbR

    collaborator UNKNOWN

  • CathVision ApS

    lead INDUSTRY

Principal Investigators

  • Josef Kautzner, Prof. · IKEM, Prague, Czech Republic

  • Peter K Jacobsen, MD, DMSc · Righospitalet, Copenhagen, Denmark

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-02
Primary Completion
2021-07-09
Completion
2021-08-01

Countries

  • Czechia
  • Denmark

Study Locations

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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 NCT05114382 on ClinicalTrials.gov