Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control arm | Cryoballoon PVI procedure where the freeze was initiated based on the occlusion assessed using fluoroscopy |
| |
| Kodex arm | Cryoballoon PVI where the freeze was initiated based on the outcome of the KODEX occlusion Viewer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KODEX-EPD System | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | up to approximately 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Pregnant women.
Not provided
Not provided
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
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hopkins University | Baltimore | Maryland | 21205 | United States | ||
| UZ Brussel |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 2, 2023 | |
| Reset | Dec 13, 2023 |
Not provided
| 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 | Jan 31, 2022 | Feb 14, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 2, 2023 | Dec 13, 2023 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D005471 | Fluoroscopy |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fluoroscopy with contrast dye | Device | Fluoroscopy with contrast dye is used to determine occlusion status during cryoballoon PVI procedures |
|
| Brussels |
| 1090 |
| Belgium |
| D013568 |
| Pathological Conditions, Signs and Symptoms |