Clinical trial NCT05931835: Feasibility Study on the VERAFEYE System
Official title: Luma Vision's Feasibility Study on the VERAFEYE System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Septal Defect
Atrial Fibrillation
Atrial Arrhythmia
Left Atrial Appendage Closure
Lead sponsor: LUMA Vision Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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 women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the ablation, or LAA/ASD closure procedure)
* Life expectancy less than 12 months
* Subjects who are currently enrolled in another study
* Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging

Primary outcomes:
measure: Physician Feedback on VERAFEYE System
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Private Network
state: Leinster
Study officials:
References: