NCT04438395

Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: EPD Solutions, A Philips Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation and Flutter

Interventions

Type	Name	Description
DEVICE	Cardiac ablation via catheter	Cardiac ablation with a catheter to treat atrial flutter and/or atrial fibrillation

Timeline

• Start date: 2020-07-20
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-06-18
• Last updated: 2022-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study