PROOF: Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Freeze success of the KODEX-EPD Occlusion Viewer
Study Overview
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 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
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Pregnant women.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported