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

Korábbi kezelés

• EC1: Any of the following within 6 months prior to/at the time of enrolment:
• j. Prior atrial surgery or atrial ablation (with the exception of cavotricuspid isthmus (CTI) ablation for atrial flutter (AFL))
• e. Any planned surgical or endovascular intervention within 30 days before or after the ablation 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)
• 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.

Más betegség

• 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
• EC2: Any of the following cardiovascular conditions:
• 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)
• 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
• 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
• 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

Laborértékek

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

Egyéb

• e. Confirmed LA thrombus on imaging*
• a. Dilated or hypertrophic cardiomyopathy
• b. Carotid stenting or endarterectomy
• d. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
• 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
• 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
• p. Subject is considered part of vulnerable population

• 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