NCT05373862已完成不适用
Clinical Evaluation of Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s)
研究概览
简要总结
The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with and candidate for clinically-indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included)
- •At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months of enrollment
- •Signed participants Informed Consent Form (ICF)
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements
排除标准
- •Diagnosed with an arrhythmia requiring epicardial mapping
- •Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause
- •Atrial arrhythmias: participants with a left atrial size greater than (>) 55 millimeters (mm)
- •Left Ventricular Ejection Fraction (LVEF) less than or equal to (<=) 25 percent (%) for participants with ventricular arrhythmia
- •LVEF <= 40% for participants with atrial arrhythmia
- •Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter
- •Contraindication to anticoagulation (that is heparin, warfarin, dabigatran)
- •History of blood clotting or bleeding abnormalities (example, hypercoagulable state)
- •Myocardial infarction within the past 2 months (60 days)
- •Documented thromboembolic event (including Transient Ischemic Attack [TIA]) within the past 12 months (365 days)
- •Uncontrolled heart failure or New York Heart Association (NYHA) function class IV
- •Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days)
- •Participants with known untreatable allergy to contrast media
- •Active illness or active systemic infection or sepsis
- •Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- •Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
- •Any cardiac surgery within the past 60 days (2 months) (includes Percutaneous Coronary Intervention [PCI])
- •Atrial septal closure within the past 6 weeks (42 days)
- •Presence of a condition that precludes vascular access
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
- •Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being
- •Concurrent enrollment in an investigational study evaluating another device or drug
结局指标
主要结局
Number of Participants With Pre-ablation Mapping Requirements and Clinically Indicated Mapping Performed With the Investigational Catheter Without Resort to Non-study Mapping Catheter(s)
时间窗: Up to 7 days of index procedure on Day 1
Number of participants with pre-ablation mapping requirements and clinically indicated mapping performed with the investigational catheter without resort to non-study mapping catheter(s) were reported.
Number of Participants With Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter
时间窗: Up to 7 days of index procedure on Day 1
Number of participants with SAEs within 7 days of index procedure related to the investigational catheter were reported. An adverse event (AE) is any untoward medical occurrence in a participant whether or not related to the investigational device. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
次要结局
- Number of Responders for Physician Assessment for Maneuverability and Handling(Up to 29 weeks)
- Number of Responders for Physician Assessment for Signal Collection and Quality(Up to 29 weeks)
- Number of Responders for Physician Assessment for Workflow(Up to 29 weeks)
- Number of Responders for Physician Assessment for Catheter Visualization(Up to 29 weeks)
- Number of Responders for Physician Assessment for Catheters Interactions(Up to 29 weeks)
- Number of Responders for Physician Assessment for Ability to Characterize the Tissue(Up to 29 weeks)
- Number of Responders for Physician Assessment for Catheter Design(Up to 29 weeks)
- Number of Participants With SAEs Excluding Investigational Catheter Related Within 7 Days of Index Procedure(Up to 7 days of index procedure on Day 1)
- Number of Responders for Physician Assessment for Pacing(Up to 29 weeks)
- Number of Responders for Physician Assessment for Arrhythmogenicity(Up to 29 weeks)
- Number of Responders for Physician Assessment for Design and Coverage for Confirming Pulmonary Vein Isolation (PVI)(Up to 29 weeks)
- Number of Responders for Physician Assessment for Ability to Identify Arrhythmia Circuit or Source Correctly(Up to 29 weeks)
- Number of Participants With Non-serious Adverse Events Within 7 Days of Index Procedure Related to the Investigational Catheter(Up to 7 days of index procedure on Day 1)
研究者
研究点 (8)
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