The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System

March 4, 2024 updated by: CathVision ApS

The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)

Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF.

Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.

The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for a cardiac ablation for the treatment of persistent atrial fibrillation

Description

Inclusion Criteria:

  • Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
  • Male or non-pregnant female aged ≥ 21 years.
  • Able and willing to provide written informed consent prior to any clinical investigation related procedure.

Exclusion Criteria:

  • Current participation in another investigational drug or device study that interferes with this study.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Life expectancy less than 12 month, in the opinion of the Investigator.
  • Subjects who, in the opinion of the investigator, are not candidates for this study.
  • Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician feedback on algorithm performance
Time Frame: One day - day of procedure
Data collected during the study will be used to test a signal complexity visualization algorithm evaluated as the technical success of the CathVision ECGenius System to collect and record intracardiac signals during ablation procedures for the treatment of persistent atrial fibrillation.
One day - day of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of AF Cycle Length
Time Frame: One day - day of procedure
Data collected during the study will be used to test an AF cycle length algorithm
One day - day of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CathVision ApS

Collaborators

AKRN Consulting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2023

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CathVision

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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