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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled AFL and AF Patients | All subjects that are enrolled are group one, as there is only one group of subjects in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac ablation via catheter | Device | Cardiac ablation with a catheter to treat atrial flutter and/or atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure |
| The feasibility of KODEX-EPD tissue thickness application |
| 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. | During procedure |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anneleen Viville | Contact | +32479983495 | Anneleen.Viville@philips.com |
| Name | Affiliation | Role |
|---|---|---|
| Larry Chinitz, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 9, 2023 | |
| Reset | Jan 26, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 9, 2023 | Jan 26, 2024 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |