Status:
UNKNOWN
Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation
Lead Sponsor:
EPD Solutions, A Philips Company
Conditions:
Atrial Fibrillation and Flutter
Eligibility:
All Genders
18+ years
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 functi...
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 functi...
Eligibility Criteria
Inclusion
- 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.
- A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
- Subject is deemed amenable to therapeutic ablation for atrial flutter or atrial fibrillation.
Exclusion
- Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
- Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- Patient had experienced previous stroke (TIA or CVA).
- Thrombi detected in the heart.
- Known marked valvular insufficiency (moderate-severe and severe)
- Life expectancy less than 12 months.
- 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).
- Subjects that according to the clinical judgment of the caring physician do not fit for the study.
- Previous right atrial ablation procedure or cardiac ablation procedure performed within 90 days prior to enrollment.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04438395
Start Date
July 20 2020
End Date
June 30 2022
Last Update
May 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Langone Health
New York, New York, United States, 10016