Feasibility Study on the VERAFEYE System (NCT05931835) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study on the VERAFEYE System
Ireland18 participantsStarted 2025-01-09
Plain-language summary
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.
Who can participate
Age range18 Years – 80 Years
SexALL
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Key Inclusion Criteria:
* Subject is 18 to 80 years of age at the time of consent
* Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure
* Subject is able to understand and willing to provide written informed consent
Key Exclusion Criteria:
* Any of the following within 6 months prior to enrolment:
* Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
* Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances
* Myocardial infarction
* Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
* Dilated or hypertropic cardiomyopathy
* Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure.
* Any of the following cardiac conditions:
* New York Heart Association (NYHA) class IV
* Left ventricular ejection fraction (LVEF) \< 30%
* Implanted with a cardiac rhythm management device (pacemaker, CRT, ICD, loop recorder)
* Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
* Active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
* Body mass index (BMI) \> 40 kg/m2
* Body weight \< 50kg
* Pregnant wome…