Atrium; FibrillationPROOFNCT04293198
Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
An observational study of Atrium; Fibrillation and Ablation, run by EPD Solutions, A Philips Company at 2 sites in 2 countries.
Trial summary
Prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the KODEX-EPD PV occlusion viewer. This study includes patients with atrial fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Atrium; Fibrillation, Ablation
- What is being tested?
- KODEX-EPD System and Fluoroscopy with contrast dye
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Nov 2020to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Arrhythmia patients scheduled to undergo a cryo balloon ablation procedure for their atrium fibrillation. Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study
Who may be able to join
- Subject must be aged >18 years.
- Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
- Subject must be willing to comply with the protocol requirements.
- Subject receives a de novo ablation procedure for treatment of atrial fibrillation.
Who cannot join
- 1. Pregnant women.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: PROOF: Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
Prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the KODEX-EPD PV occlusion viewer. This study includes patients with atrial fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial fibrillation.
Read the detailed description
The study is designed to evaluate the performance of the KODEX-EPD occlusion viewer using a standardized workflow in a blinded setting in a homogenous patient group. Furthermore, in an effort to minimize therapy, a direct comparison between the success of the freeze when initiating therapy based on the occlusion viewer vs the assessment of occlusion assessed with fluoroscopy will be evaluated. The study design indicates a post-market interventional clinical investigation to evaluate the endpoints of the study. No follow-up is foreseen ensuring a minimal burden to the subjects participating in the study.
- Conditions
- Atrium; Fibrillation, Ablation
- Being tested
- KODEX-EPD System, Fluoroscopy with contrast dye
- Keywords
- Atrial Fibrillation, AF, Cryoballoon, Ablation, KODEX-EPD
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KODEX-EPD SystemDevice
Also called KODEX Occlusion Viewer
The KODEX - EPD system is an open platform that uses any validated EP catheter to create real-time 3D images of the human heart. The KODEX occlusion viewer provides an indication of the occlusion status of the PV during cryoballoon PVI procedure
Fluoroscopy with contrast dyeDevice
Fluoroscopy with contrast dye is used to determine occlusion status during cryoballoon PVI procedures
| Study group | Role | What they receive |
|---|---|---|
| control arm | Cryoballoon PVI procedure where the freeze was initiated based on the occlusion assessed using fluoroscopy Receives: Device: Fluoroscopy with contrast dye | |
| Kodex arm | Cryoballoon PVI where the freeze was initiated based on the outcome of the KODEX occlusion Viewer Receives: Device: KODEX-EPD System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the KODEX-EPD Occlsuion Viewer
The primary effectiveness endpoint is the accuracy, sensitivity, specificity and positive and negative predictive values of the KODEX-EPD PV occlusion feature as compared to conventional angiographic method of fluoroscopy with contrast dye that will be used to guide the procedure.
Measured: up to approximately 6 months
Freeze success of the KODEX-EPD Occlusion Viewer
The success of the freeze when freeze is initiated based on the assessment of the KODEX-EPD PV occlusion feature as compared to the success of the freeze when freeze is initiated based on the assessment with fluoroscopy and contrast dye.
Measured: up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start4 Nov 2020
- Primary completion30 Aug 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrium; FibrillationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- EPD Solutions, A Philips Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293198
- Sponsor's protocol ID
- CLN-KODEX-0019
- Acronym
- PROOF
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROOF: Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04293198
- Acronym / sponsor ID
- PROOF / CLN-KODEX-0019
- Conditions
- Atrium; Fibrillation, Ablation
- Keywords
- Atrial Fibrillation, AF, Cryoballoon, Ablation, KODEX-EPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- EPD Solutions, A Philips CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the KODEX-EPD PV occlusion viewer. This study includes patients with atrial fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial fibrillation.
Detailed description
The study is designed to evaluate the performance of the KODEX-EPD occlusion viewer using a standardized workflow in a blinded setting in a homogenous patient group. Furthermore, in an effort to minimize therapy, a direct comparison between the success of the freeze when initiating therapy based on the occlusion viewer vs the assessment of occlusion assessed with fluoroscopy will be evaluated. The study design indicates a post-market interventional clinical investigation to evaluate the endpoints of the study. No follow-up is foreseen ensuring a minimal burden to the subjects participating in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | – | Device: Fluoroscopy with contrast dyeCryoballoon PVI procedure where the freeze was initiated based on the occlusion assessed using fluoroscopy |
| Kodex arm | – | Device: KODEX-EPD SystemCryoballoon PVI where the freeze was initiated based on the outcome of the KODEX occlusion Viewer |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Arrhythmia patients scheduled to undergo a cryo balloon ablation procedure for their atrium fibrillation. Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study
Key inclusion criteria (4 listed)
- Subject must be aged >18 years.
- Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
- Subject must be willing to comply with the protocol requirements.
- Subject receives a de novo ablation procedure for treatment of atrial fibrillation.
Key exclusion criteria (1 listed)
- 1. Pregnant women.
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 |
|---|---|---|
| KODEX-EPD SystemAlso: KODEX Occlusion ViewerThe KODEX - EPD system is an open platform that uses any validated EP catheter to create real-time 3D images of the human heart. The KODEX occlusion viewer provides an indication of the occlusion status of the PV during cryoballoon PVI procedure | Device | Kodex arm |
| Fluoroscopy with contrast dyeFluoroscopy with contrast dye is used to determine occlusion status during cryoballoon PVI procedures | Device | control arm |
Primary outcome
Effectiveness of the KODEX-EPD Occlsuion Viewer
Time frame: up to approximately 6 months
The primary effectiveness endpoint is the accuracy, sensitivity, specificity and positive and negative predictive values of the KODEX-EPD PV occlusion feature as compared to conventional angiographic method of fluoroscopy with contrast dye that will be used to guide the procedure.
Freeze success of the KODEX-EPD Occlusion Viewer
Time frame: up to approximately 6 months
The success of the freeze when freeze is initiated based on the assessment of the KODEX-EPD PV occlusion feature as compared to the success of the freeze when freeze is initiated based on the assessment with fluoroscopy and contrast dye.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrium; Fibrillation and Ablation, run by EPD Solutions, A Philips Company at 2 sites in 2 countries.
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 4 inclusion and 1 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness of the KODEX-EPD Occlsuion Viewer (time frame: up to approximately 6 months). 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?
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 16 Feb 2023.