Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter (an Exploratory Investigation)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 7
- 主要终点
- Incidence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping
研究概览
简要总结
The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 (participant 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 prior to enrollment
- •Age 18 years or older
- •Signed Patient Informed Consent Form (ICF)
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements
排除标准
- •Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause
- •Patients requiring left atrial procedures: left atrial size greater than (>) 55 millimeter (mm)
- •Left ventricular ejection fraction(LVEF) less than or equal to (<=) 25 percentage (%) 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 or appendage closure device within the past 6 weeks (42 days)
- •Patients 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)
- •Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior
- •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
研究组 & 干预措施
Arrhythmia Mapping by a Paddle-shaped, High-density, Multi-electrode Mapping Catheter
Participants scheduled to have a clinically indicated mapping and ablation procedure for the management of cardiac arrhythmias. The investigational paddle-shaped, high-density, multi-electrode catheter is used for mapping purposes only.
干预措施: Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter (Device)
结局指标
主要结局
Incidence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping
时间窗: Up to 7 days post index procedure
A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Incidence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping
时间窗: Up to 7 days post index procedure
Incidences of all pre-ablation endocardial mapping requirements and any clinically indicated endocardial mapping with the investigational catheter, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.
Occurrence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping
时间窗: Up to 7 days post index procedure
A SAE is any AE that led to any of the following: (1) Death; (2) Serious deterioration in the health of a participant that resulted in any of the following: Life-threatening illness or injury; Permanent impairment of a body structure or a body function; In-patient hospitalization or prolongation of patient hospitalization; Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; Chronic disease. (3) Fetal distress, fetal death or a congenital physical or mental impairment or birth defect.
Occurrence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping
时间窗: Up to 7 days post index procedure
Occurrence of all pre-ablation endocardial mapping requirements and any clinically indicated endocardial mapping with the investigational catheter, without resort to non-investigational mapping catheter due to an inadequacy or inability of the investigational catheter to perform the required arrhythmia mapping will be reported.
次要结局
- Investigator Assessment of Deployment; Visualization; Maneuverability and Signal Quality(Up to 7 days post index procedure)
- Incidence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion(Up to 7 days post index procedure)
- Incidence of all Other SAEs Not Related to the Investigational Catheter(Up to 7 days post index procedure)
- Incidence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter(Up to 7 days post index procedure)
- Incidence of Completion of all Pre-ablation Epicardial Mapping Requirements and Any Clinically Indicated Epicardial Mapping With the Investigational Catheter as Per Physician's Discretion(Up to 7 days post index procedure)
- Occurrence of SAEs Related to the Investigational Catheter When Used for Epicardial Mapping as per Physician's Discretion(Up to 7 days post index procedure)
- Occurrence of all Other SAEs Not Related to the Investigational Catheter(Up to 7 days post index procedure)
- Occurrence of Non-serious Adverse Events (AEs) Related to the Investigational Catheter(Up to 7 days post index procedure)
- Occurrence of Completion of all Pre-ablation Epicardial Mapping Requirements and Any Clinically Indicated Epicardial Mapping With the Investigational Catheter as Per Physician's Discretion(Up to 7 days post index procedure)