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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04438395
Study type Observational
Source EPD Solutions, A Philips Company
Contact Anneleen Viville
Phone +32479983495
Email Anneleen.Viville@philips.com
Status Recruiting
Phase
Start date July 20, 2020
Completion date June 30, 2022

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