A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation System

NCT07686328 | Not Yet Recruiting FDA Device

• 1 other identifier: PRISM-P006
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

PRISM: A Multicenter Feasibility Study with the VERAFEYE Imaging and Guidance System as Anatomical Navigation System

Conditions

Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Acute Performance

  Proportion of procedures in which the pre-specified anatomical lesion set was completed using the VERAFEYE anatomical model for navigation (PAF: PV lesions; perAF: PV lesions plus adjunctive atrial lesions as determined by the Investigator).

  At the end of the index procedure

Secondary Outcomes (3)

• Feasibility of Workflow

  At the end of the index procedure

• Procedural Efficiency

  During the index procedure

• Safety Events

  Index Procedure-7 Days FU

Study Arms (1)

Paroxysmal/persistent AF

EXPERIMENTAL

Adult patients indicated to undergo a catheter ablation procedure for the treatment of paroxysmal atrial fibrillation (PAF), or persistent atrial fibrillation (perAF)

Device: Catheter Ablation

Interventions

Catheter Ablation DEVICE

The study will utilize the VERAFEYE Imaging and Guidance System for real-time imaging and anatomical navigation in combination with a commercially approved and VIS-compatible ablation system. The choice of the ablation system is per physician discretion.

Paroxysmal/persistent AF

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 access, catheter introduction, or manipulation
• e. Unstable angina
• f. Moderate to severe mitral valve stenosis or other severe valvular disease
• g. Active coronary ischemia, or hemodynamically significant congenital cardiac abnormality
• h. Any blood clotting or bleeding abnormalities

Sponsors & Collaborators

• LUMA Vision Ltd.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Alisa Komleva

CONTACT

+353 89 435 20 47; alisa.komleva@lumavision.com

Elke Sommerijns

CONTACT

+32 479 76 71 56; Elke.sommerijns@lumavision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06