Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation

Completed

Conditions studied: Atrium; Fibrillation, Ablation

In brief

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.

Key facts

Study ID

NCT04293198

Run by

EPD Solutions, A Philips Company

People needed

63

Starts

2020-11-04

Expected to finish

2023-01-31

Last updated by the study team

2023-02-16

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant women.

Where it is running

• John Hopkins University — Baltimore, Maryland, United States
• UZ Brussel — Brussels, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.