Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation

• Conditions: Atrial Fibrillation and Flutter
• Interventions: Device: Cardiac ablation via catheter

• Registration Number: NCT04438395
• Lead Sponsor: EPD Solutions, A Philips Company

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 Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Study Start: 2020-07-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Subject must be aged >18 years.
2. Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
3. Subject must be willing to comply with the protocol requirements.
4. A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
5. Subject is deemed amenable to therapeutic ablation for atrial flutter or atrial fibrillation.

Exclusion Criteria

1. Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
2. Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
3. Patient had experienced previous stroke (TIA or CVA).
4. Thrombi detected in the heart.
5. Known marked valvular insufficiency (moderate-severe and severe)
6. Life expectancy less than 12 months.
7. Known severe renal insufficiency (stages G4 and G5, characterized by severe reduction in GFR [15-29 ml/min/1.73 m2] and GFR [<15 ml/min/1.73 m2], respectively).
8. Subjects that according to the clinical judgment of the caring physician do not fit for the study.
9. Previous right atrial ablation procedure or cardiac ablation procedure performed within 90 days prior to enrollment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled AFL and AF Patients	Cardiac ablation via catheter	All subjects that are enrolled are group one, as there is only one group of subjects in this study

Primary Outcome Measures

Name	Time	Method
The feasibility of KODEX-EPD tissue pressure (TP) application	During procedure	• will be evaluated based on comparison with qualitative assessment of catheter contact by the physician during the procedure. We will ask the physician to estimate the level of pressure applied by categorizing the pressure as: no touch, touch (light), touch (firm), or high touch.
The feasibility of KODEX-EPD tissue thickness application	During procedure	* thickness values will be evaluated by checking whether they are in the range of what can be expected based on feedback from the physician upon review after the treatment (measured in mm); * reproducibility of thickness assessment with KODEX-EPD will be calculated from repeat assessments of the same line (measured in mm); * relative thickness values will be compared against relative thickness values measured with ICE (measured in mm); * relative thickness values will be compared against relative thickness values derived from pre-procedural CT (measured in mm)
The feasibility of KODEX-EPD lesion transmurality application	During procedure	• will be evaluated by checking whether assessments are reasonable from what can be expected based on feedback from the physician upon review after the treatment. The physician's response will be recorded as yes or no for transmurality.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States