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

ConditionsParoxysmal Atrial FibrillationPersistent Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorLUMA Vision Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Paroxysmal/persistent AFExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
At the end of the index procedure

Secondary outcomes

1

Feasibility of Workflow

As assessed by operator by means of a questionnaire (formative evaluation approach)

Time frame
At the end of the index procedure
2

Procedural Efficiency

* VERAFEYE Imaging Catheter (VIC) pullback time(s) * Time from VIC insertion until 3D anatomical model creation * Time required for manual segmentation * Time from VIC insertion until first ablation application * Total procedure time, defined as time from first venous access to time of removal of last sheath

Time frame
During the index procedure
3

Safety Events

Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure, as adjudicated by a Medical Reviewer

Time frame
Index Procedure-7 Days FU

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LUMA Vision Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: