NCT07686328尚未招募不适用
A Multicenter Feasibility Study With the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Acute Performance
研究概览
简要总结
PRISM: A Multicenter Feasibility Study with the VERAFEYE Imaging and Guidance System as Anatomical Navigation System
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Acute Performance
时间窗: At the end of the index procedure
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).
次要结局
- Feasibility of Workflow(At the end of the index procedure)
- Procedural Efficiency(During the index procedure)
- Safety Events(Index Procedure-7 Days FU)
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