Status:
COMPLETED
Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
Lead Sponsor:
EPD Solutions, A Philips Company
Conditions:
Atrium; Fibrillation
Ablation
Eligibility:
All Genders
18-120 years
Brief 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 sc...
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 minim...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Pregnant women.
Key Trial Info
Start Date :
November 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04293198
Start Date
November 4 2020
End Date
January 31 2023
Last Update
February 16 2023
Active Locations (2)
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1
John Hopkins University
Baltimore, Maryland, United States, 21205
2
UZ Brussel
Brussels, Belgium, 1090