The Automated Calculation of AF Cycle Length and Complexi... | NCT05477602

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

NCT05477602

Sponsor

CathVision ApS

Status

Completed

Last Update Posted

Jan 30, 2026Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Cardiac Ablation for the treatment of persistent Atrial Fibrillation

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2023Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2024Actual

First Submitted Date

Jul 25, 2022

First Submission Date that Met QC Criteria

Jul 26, 2022

First Posted Date

Jul 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Jan 14, 2026

Results First Submitted that Met QC Criteria

Jan 14, 2026

Results First Posted Date

Jan 30, 2026Actual

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2026

Last Update Posted Date

Jan 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Ablation for the treatment of persistent Atrial Fibrillation	Procedure	Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation		Persistent AF Ablation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
OLV Aalst		Aalst		9300	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Title	Description
FG000	Full Cohort	All patients recruited

Baseline Characteristics Module

Baseline Analysis Population Description

1 patient did not meet the eligibility criteria after screening

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Full Cohort	All 21 patients in the PPT group

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Measurement of AF Cycle Length

Data collected during the study will be used to test an AF cycle length algorithm

Posted

Mean

Standard Deviation

One day - day of procedure

ID	Title	Description
OG000	Full Cohort	All enrolled patients

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

Enrollment until hospital discharge, up to 3 days

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Full Cohort	All patients recruited	0

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bleeding from the groin	Vascular disorders		Systematic Assessment	The patient had bleeding from the vascular entry site in the groin which required a prolonged hospital stay.

Other Adverse Events

Not provided

Title	Organization	Phone	Extension	Email
Karl Firth	CathVision ApS	0702097102		kpf@cathvision.com

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 24, 2022	Jan 14, 2026	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided