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

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

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

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

Study Objective: The objective of this feasibility study is to

• collect data on the use of the VERAFEYE Imaging and Guidance System (VIS)
• assess procedural workflow across operators and sites
• characterize overall procedural efficiency across operators and sites in adult patients indicated to undergo a catheter ablation procedure for the treatment of paroxysmal atrial fibrillation (PAF), or persistent atrial fibrillation (perAF). The study will utilize the VIS 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.

In order to evaluate procedural efficiency, metrics will include, but are not limited to:

• VERAFEYE Imaging Catheter (VIC) pullback time(s)
• Time from VIC insertion until 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 The above metrics will be analyzed and reported separately for each patient group (PAF and perAF).

Indication for Use:

The VIS is intended for cardiac applications. The system provides 2D & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures for the evaluation of the presence or absence of pathology.

The VIS is also intended for catheter-based cardiac electrophysiological (EP) procedures in the Left Atrium (LA) and Right Atrium (RA). The VIS provides the reconstruction of chamber geometry from ultrasound data, and visualization of the chamber anatomy and intracardiac catheter location during procedures.

Study (Test Devices, Investigationally-Labeled):

• VERAFEYE™ Imaging Catheter (VIC)
• VERAFEYE™ Imaging and Guidance System (VIS) with the following components:
• Catheter Interface Unit (CIU)
• System Console (SC)
• Ablation Interface (ABI)
• Accessories to the VIS

Other Devices (to be used in the study but not the subject of this clinical study):

•Commercially approved and VIS-compatible ablation system. The choice of the ablation system is per physician discretion.

Study Design: This study is a prospective, non-randomized, single-arm, multi-center feasibility study.

Planned Number of Subjects: Up to 50 Procedure subjects will be enrolled in the study. Subjects indicated for a catheter ablation procedure for PAF/perAF with a commercially approved and VIS-compatible ablation system will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the informed consent form. Subjects who have signed and dated the informed consent form are considered enrolled in the study.

Planned Number of Sites/Countries: Up to 10 sites in the United States may participate in this study. To account for expected site and operator variability, multi-center, multi-operator enrollment is required:

• Each site may initially enroll a maximum of 10 Procedure subjects, unless LUMA Vision provides written approval to exceed this number.
• Each operator may initially enroll a maximum of 5 Procedure subjects, unless LUMA Vision provides written approval to exceed this number.

It is recommended that the number of operators is restricted to 3 per site. Subject treatment will follow a sequential pattern (one site after the other) to allow LUMA Vision field support personnel to be present during the procedures and to ensure the availability and installation of necessary medical equipment. Running multiple labs within a single site at the same time is not permitted.

Study Endpoints: This is a feasibility study, no formal endpoints or hypothesis testing are planned in the study. Safety and performance will be described using descriptive statistics; no safety or effectiveness claims will be made based on the results of this study.

Analyses: Analyses include but are not limited to:

• 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).
• Feasibility of Workflow: As assessed by operator by means of a questionnaire (formative evaluation approach)
• Procedural Efficiency:
• 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
• Safety: Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure, as adjudicated by a Medical Reviewer

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 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

• i. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality

• j. Prior atrial surgery or atrial ablation (with the exception of cavotricuspid isthmus (CTI) ablation for atrial flutter (AFL))

• k. History of ventricular tachycardia or ventricular fibrillation

• EC3: Any of the following (conditions) at baseline:

• a. New York Heart Association (NYHA) class III or IV

• b. Left ventricular ejection fraction (LVEF) < 40%

• c. LA diameter >2.17 in or if LA diameter is not available, LA non-indexed volume > 3.38 fl oz (if both values are available, only the LA diameter will be used to confirm eligibility)

• d. Any contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation

• e. Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure

• f. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition

• g. Renal failure requiring dialysis or transplant

• h. Acute illness, active systemic infection, or sepsis

• i. Body mass index (BMI) > 40 lbs/in2

• j. Body weight < 110 lbs

• k. Subjects where placement of VIC is technically not feasible per physician discretion

• l. Any contra-indication that may extend procedure time, at the discretion of the operator

• m. Life expectancy less than 12 months

• n. Unrecovered/unresolved Adverse Events from any previous invasive procedure

• o. 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 procedure)

• p. Subject is considered part of vulnerable population

• q. Subject is currently enrolled in another study that would directly interfere with this study. Each instance must be approved by the Sponsor in writing prior to enrolling the subject in the study.

  • Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening is per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.

Index Procedure: At the Index Ablation Procedure, general anesthesia or (deep) sedation may be used per Investigator discretion. During the procedure, the VIS will be used to create 3D anatomical models of the LA (and RA, as applicable) and provide real-time 2D and 4D intracardiac echo (ICE) imaging, which in combination will be used for catheter navigation and lesion placement during the ablation procedure. Standard access tools, sheaths, and catheters for diagnostic purposes will be utilized and remain consistent with the site's standard of care for the procedure.

Subject Follow-Up: After completion of the index ablation procedure, participants will undergo follow-up evaluations at hospital discharge and again at 7 days (+3 days).

Study Duration and Participant Duration: Enrollment in the study is expected to be completed in approximately 6 months. Since subject follow-up is approximately 7 days, the total study duration is approximately 6 months.

Statistical Methods: Analysis of study data will use descriptive statistical methods.

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 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

• i. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality

• j. Prior atrial surgery or atrial ablation (with the exception of cavotricuspid isthmus (CTI) ablation for atrial flutter (AFL))

• k. History of ventricular tachycardia or ventricular fibrillation

• EC3: Any of the following (conditions) at baseline:

• a. New York Heart Association (NYHA) class III or IV

• b. Left ventricular ejection fraction (LVEF) < 40%

• c. LA diameter >2.17 in or if LA diameter is not available, LA non-indexed volume > 3.38 fl oz (if both values are available, only the LA diameter will be used to confirm eligibility)

• d. Any contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation

• e. Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure

• f. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition

• g. Renal failure requiring dialysis or transplant

• h. Acute illness, active systemic infection, or sepsis

• i. Body mass index (BMI) > 40 lbs/in2

• j. Body weight < 110 lbs

• k. Subjects where placement of VIC is technically not feasible per physician discretion

• l. Any contra-indication that may extend procedure time, at the discretion of the operator

• m. Life expectancy less than 12 months

• n. Unrecovered/unresolved Adverse Events from any previous invasive procedure

• o. 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 procedure)

• p. Subject is considered part of vulnerable population

• q. Subject is currently enrolled in another study that would directly interfere with this study. Each instance must be approved by the Sponsor in writing prior to enrolling the subject in the study.

  • Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening is per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled be performed within 30 days post ICF signature, provided that the thrombus is no longer present.