A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navig… (NCT07686328) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
50 participantsStarted 2026-08-01
Plain-language summary
PRISM: A Multicenter Feasibility Study with the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* IC1: Subject is at least 22 years of age at the time of consent, or older as required by local law
* IC2: Subject has documented PAF/perAF
* IC3: Subject is scheduled to undergo a catheter-ablation procedure to treat PAF/perAF with a commercially-approved and VIS-compatible ablation system
* IC4: Subject is able to understand and willing to provide written informed consent
* IC5: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site
Exclusion Criteria:
* EC1: Any of the following within 6 months prior to/at the time of enrolment:
* a. Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotom
* b. Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbance
* c. Myocardial infarction
* d. Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
* e. Confirmed LA thrombus on imaging\*
* EC2: Any of the following cardiovascular conditions:
* a. Dilated or hypertrophic cardiomyopathy
* b. Carotid stenting or endarterectomy
* c. Subjects implanted with an active cardiac implantable electronic device (CIED) providing pacing and/or defibrillation therapy (e.g. pacemaker, CRT device, ICD) (subjects with an implantable loop recorder (ILR) are eligible for enrollment)
* d. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular acce…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.