Atrial Fibrillation and FlutterERUCANCT04438395
Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation
An observational study of Atrial Fibrillation and Flutter, run by EPD Solutions, A Philips Company at 1 site in United States.
Trial summary
This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation and Flutter
- What is being tested?
- Cardiac ablation via catheter
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2020to 30 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Atrial Flutter and patients with Atrial Fibrillation scheduled to undergo RF ablation of the cavotricuspid isthmus (CTI). 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.
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
- Subject is deemed amenable to therapeutic ablation for atrial flutter or atrial fibrillation.
Who cannot join
- Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- Patient had experienced previous stroke (TIA or CVA).
- Thrombi detected in the heart.
- Known marked valvular insufficiency (moderate-severe and severe)
- Life expectancy less than 12 months.
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- Known severe renal insufficiency (stages G4 and G5, characterized by severe reduction in GFR [15-29 ml/min/1.73 m2] and GFR [<15 ml/min/1.73 m2], respectively).
- Subjects that according to the clinical judgment of the caring physician do not fit for the study.
- Previous right atrial ablation procedure or cardiac ablation procedure performed within 90 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
April Jacob, 212-263-7704, April.Jacob@nyulangone.org
Chinitz
About this study
This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.
Read the detailed description
This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality. The study will include up to 30 subjects. We will enroll patients with atrial flutter and patients with atrial fibrillation who are scheduled to undergo RF ablation of the cavotricuspid isthmus (CTI). Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study. We will be assessing the feasibility of the KODEX-EPD tissue pressure (TP), tissue thickness and lesion transmurality applications.
- Conditions
- Atrial Fibrillation and Flutter
- Being tested
- Cardiac ablation via catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac ablation via catheterDevice
Cardiac ablation with a catheter to treat atrial flutter and/or atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Enrolled AFL and AF Patients | All subjects that are enrolled are group one, as there is only one group of subjects in this study Receives: Device: Cardiac ablation via catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of KODEX-EPD tissue pressure (TP) application
- will be evaluated based on comparison with qualitative assessment of catheter contact by the physician during the procedure. We will ask the physician to estimate the level of pressure applied by categorizing the pressure as: no touch, touch (light), touch (firm), or high touch.
Measured: During procedure
The feasibility of KODEX-EPD tissue thickness application
- thickness values will be evaluated by checking whether they are in the range of what can be expected based on feedback from the physician upon review after the treatment (measured in mm)
- reproducibility of thickness assessment with KODEX-EPD will be calculated from repeat assessments of the same line (measured in mm)
- relative thickness values will be compared against relative thickness values measured with ICE (measured in mm)
- relative thickness values will be compared against relative thickness values derived from pre-procedural CT (measured in mm)
Measured: During procedure
The feasibility of KODEX-EPD lesion transmurality application
- will be evaluated by checking whether assessments are reasonable from what can be expected based on feedback from the physician upon review after the treatment. The physician's response will be recorded as yes or no for transmurality.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start20 Jul 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation and FlutterStudies 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
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EPD Solutions, A Philips Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Chinitz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438395
- Sponsor's protocol ID
- CLN-00016
- Acronym
- ERUCA
- Status last verified
- May 2022
- First submitted
- 18 May 2020
- Last updated
- 6 May 2022
- 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 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation
- ClinicalTrials.gov ID
- NCT04438395
- Acronym / sponsor ID
- ERUCA / CLN-00016
- Conditions
- Atrial Fibrillation and Flutter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- EPD Solutions, A Philips CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 18 Jun 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.
This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.
Detailed description
This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality. The study will include up to 30 subjects. We will enroll patients with atrial flutter and patients with atrial fibrillation who are scheduled to undergo RF ablation of the cavotricuspid isthmus (CTI). Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study. We will be assessing the feasibility of the KODEX-EPD tissue pressure (TP), tissue thickness and lesion transmurality applications.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled AFL and AF Patients | – | Device: Cardiac ablation via catheterAll subjects that are enrolled are group one, as there is only one group of subjects in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Atrial Flutter and patients with Atrial Fibrillation scheduled to undergo RF ablation of the cavotricuspid isthmus (CTI). Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study.
Key inclusion criteria (5 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.
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
- Subject is deemed amenable to therapeutic ablation for atrial flutter or atrial fibrillation.
Key exclusion criteria (9 listed)
- Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- Patient had experienced previous stroke (TIA or CVA).
- Thrombi detected in the heart.
- Known marked valvular insufficiency (moderate-severe and severe)
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 |
|---|---|---|
| Cardiac ablation via catheterCardiac ablation with a catheter to treat atrial flutter and/or atrial fibrillation | Device | Enrolled AFL and AF Patients |
Primary outcome
The feasibility of KODEX-EPD tissue pressure (TP) application
Time frame: During procedure
• will be evaluated based on comparison with qualitative assessment of catheter contact by the physician during the procedure. We will ask the physician to estimate the level of pressure applied by categorizing the pressure as: no touch, touch (light), touch (firm), or high touch.
The feasibility of KODEX-EPD tissue thickness application
Time frame: During procedure
* thickness values will be evaluated by checking whether they are in the range of what can be expected based on feedback from the physician upon review after the treatment (measured in mm) * reproducibility of thickness assessment with KODEX-EPD will be calculated from repeat assessments of the same line (measured in mm) * relative thickness values will be compared against relative thickness values measured with ICE (measured in mm) * relative thickness values will be compared against relative thickness values derived from pre-procedural CT (measured in mm)
The feasibility of KODEX-EPD lesion transmurality application
Time frame: During procedure
• will be evaluated by checking whether assessments are reasonable from what can be expected based on feedback from the physician upon review after the treatment. The physician's response will be recorded as yes or no for transmurality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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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.
Larry Chinitz, MD principal investigator
NYU Langone Health
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 Atrial Fibrillation and Flutter, run by EPD Solutions, A Philips Company 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anneleen Viville (+32479983495, Anneleen.Viville@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of KODEX-EPD tissue pressure (TP) application (time frame: During procedure). The study lists 3 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 6 May 2022.