Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-01 @ 10:56 AM
Study NCT ID:
NCT04438395
Status:
UNKNOWN
Last Update Posted:
2022-05-06
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation
Sponsor:
EPD Solutions, A Philips Company
Organization:
Study Overview
Official Title:
Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERUCA
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: