Cardiac ArrhythmiaNCT05301803

An Evaluation of the Safety and Performance of the CathVision ECGenius® System.

An observational study of Cardiac Arrhythmia, run by CathVision ApS at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Arrhythmia
What is being tested?: Electrophysiology procedure
Type of treatment: Medical device
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 29 Mar 2022to 31 Dec 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients indicated for EP study or cardiac ablation.

Who may be able to join

Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
At least 18 years of age.
Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).

Who cannot join

Patient inability to understand or refusal to sign informed consent.
Patient is a prisoner or under incarceration
Patients who in the opinion of the physician are not candidates for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of vermont
Burlington, Vermont, 05401

Other trials in United States

About this study

Official title: A Prospective, Single-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Technical Performance of the CathVision ECGenius® System.

Read the detailed description

A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision ECGenius® system.

Patients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision ECGenius® System in parallel with a commercial EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.

Conditions: Cardiac Arrhythmia
Being tested: Electrophysiology procedure
Keywords: electrophysiology, atrial fibrillation, cardiac ablation
Medical subject headings: Arrhythmias, Cardiac, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electrophysiology procedureDevice
Electrophysiology testing and cardiac ablation of arrhythmia

What is being measured

The primary outcome is the main question the study is designed to answer.

Baseline Noise Comparison
Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV
Measured: EP and ablation procedures can take up to six hours
Freedom From Major Adverse Events, Evaluated at Hospital Discharge
Freedom from major adverse events, evaluated at hospital discharge
Adverse events were categorized as one of:
An adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device.
A Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE.
An unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
Measured: From EP procedure to discharge is usually one day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 202231 Dec 2023

First posted31 Mar 2022
Study start29 Mar 2022
Primary completion30 Apr 2022
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05301803
Sponsor's protocol ID: CP-00003-A
Status last verified: Aug 2024
First submitted: 21 Mar 2022
Last updated: 5 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
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All Cardiac Arrhythmia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-Center, Open-Label, Single-Arm Study to Evaluate the Safety and Technical Performance of the CathVision ECGenius® System.
ClinicalTrials.gov ID: NCT05301803
Acronym / sponsor ID: CP-00003-A
Conditions: Cardiac Arrhythmia
Keywords: electrophysiology, atrial fibrillation, cardiac ablation
Study type: Observational
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: CathVision ApSIndustry (pharma, biotech, devices)
Collaborators: Medicept Inc.
Study start: 29 Mar 2022 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 31 Mar 2022 (actual)
Results: Posted 5 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision ECGenius® system.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients indicated for EP study or cardiac ablation.

Key inclusion criteria (3 listed)

Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
At least 18 years of age.
Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).

Key exclusion criteria (3 listed)

Patient inability to understand or refusal to sign informed consent.
Patient is a prisoner or under incarceration
Patients who in the opinion of the physician are not candidates for this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Electrophysiology procedureElectrophysiology testing and cardiac ablation of arrhythmia	Device	–

Primary outcome

Baseline Noise Comparison
Time frame: EP and ablation procedures can take up to six hours
Measure the peak to peak baseline noise in two EP recording systems for both bipolar and unipolar electrograms in μV
Freedom From Major Adverse Events, Evaluated at Hospital Discharge
Time frame: From EP procedure to discharge is usually one day.
Freedom from major adverse events, evaluated at hospital discharge Adverse events were categorized as one of: An adverse event (AE) A serious adverse event (SAE) An Adverse device effect (ADE) is an AE related to the use of an investigational medical device. A Serious adverse device effect (SADE) is an ADE that that has resulted in any of the consequences characteristic of an SAE. An unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health, safety, any life-threatening problem, death caused by or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in predicate devices, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	27	25

Primary outcome: Baseline Noise Comparison

Time frame: EP and ablation procedures can take up to six hours. Median (Inter-Quartile Range). Unit: μV

Measure	Single Arm n = 25
ECGenius Bipolar Baseline Noise	19 (11 to 29)
ECGenius Unipolar Baseline Noise	46 (20 to 126)
LabSystem Pro Bipolar Baseline Noise	31 (22 to 38)
LabSystem Pro Unipolar Noise	463 (138 to 525)

Population analysed: Baseline noise

Primary outcome: Freedom From Major Adverse Events, Evaluated at Hospital Discharge

Time frame: From EP procedure to discharge is usually one day.. Count of participants. Unit: Participants

Measure	Single Arm n = 27
Value	26

Adverse events

Time frame: from hospital admission to discharge, typically one day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	1 of 27 (3.7%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cardiac Arrhythmia

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nathaniel C Thompson, MD PhD principal investigator

The University of Vermont Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrhythmia, run by CathVision ApS at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Noise Comparison (time frame: EP and ablation procedures can take up to six hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05301803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.