Status:
COMPLETED
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
Lead Sponsor:
CathVision ApS
Collaborating Sponsors:
Medicept Inc.
Conditions:
Cardiac Arrhythmia
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compar...
Detailed Description
A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision ECGenius® system. Patients undergoing assessment and ablation of cardiac ...
Eligibility Criteria
Inclusion
- Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
- At least 18 years of age.
- Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).
Exclusion
- Patient inability to understand or refusal to sign informed consent.
- Patient is a prisoner or under incarceration
- Patients who in the opinion of the physician are not candidates for this study.
Key Trial Info
Start Date :
March 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05301803
Start Date
March 29 2022
End Date
December 31 2023
Last Update
September 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of vermont
Burlington, Vermont, United States, 05401