A Prospective, Interventional, Single-Center, Single-Arm Clinical Investigation to Evaluate the Safety and Performance of the Newtech Diagnostic Electrophysiology Catheter for Intracardiac Mapping in Patients Undergoing Electrophysiology Studies for Cardiac Arrhythmias.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- • To confirm the clinical safety and performance of the Newtech Diagnostic Electrophysiology Catheter, demonstrated by the successful completion of the intended electrophysiological mapping procedure and the absence of any device-related serious adverse events during or immediately after the procedure.
研究概览
简要总结
This is a prospective, interventional, single-center, single-arm, open-label clinical investigation designed to evaluate the clinical safety and performance of the Newtech Diagnostic Electrophysiology Catheter in patients undergoing electrophysiological (EP) procedures for the evaluation of cardiac arrhythmias.
Eligible patients with a clinical indication for Electrophysiology mapping will be enrolled following written informed consent. The investigational device will be used for intracardiac signal acquisition and electrical stimulation from endocardial and intravascular sites, in accordance with its approved Instructions for Use (IFU) and standard electrophysiological practice. The catheter will be inserted via a central venous approach, commonly through the femoral vein, and manipulated under fluoroscopic guidance by trained electrophysiologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 years or older.
- •2.Patients with suspected or confirmed cardiac arrhythmias who are scheduled for an electrophysiology EP procedure requiring diagnostic intracardiac mapping.
- •3.Patients in stable clinical condition, suitable for elective EP studies 4.Ability to provide written informed consent prior to any study-related procedures.
- •5.Subject (or legally authorized representative) has provided written informed consent prior to enrollment.
- •6.Willing and able to comply with the protocol-required follow-up schedule.
排除标准
- •1.Presence of acute conditions that may render the EP study findings unrepresentative of the patient’s typical cardiac rhythm, including:.
- •Significant electrolyte imbalance.
- •Acute ischemia.
- •Drug toxicity 2.Hemodynamic instability or ongoing myocardial infarction at the time of enrollment. 3.Patients with unstable angina or at high risk of life-threatening arrhythmias, where induced arrhythmias may be extremely difficult to terminate. (As per IFU contraindications) 4.Known hypersensitivity or allergy to materials used in the catheter (e.g., polyurethane, stainless steel, or electrode materials). 5.Pregnant or lactating women. 6.Patients with active systemic infection or local infection at the vascular access site. 7.Patients in another interventional clinical trial within the last 30 days. 8.Any condition that, in the opinion of the investigator, would make participation in the study medically inappropriate, pose a risk to the patient, or interfere with the study objectives.
结局指标
主要结局
• To confirm the clinical safety and performance of the Newtech Diagnostic Electrophysiology Catheter, demonstrated by the successful completion of the intended electrophysiological mapping procedure and the absence of any device-related serious adverse events during or immediately after the procedure.
时间窗: Pre-operative, Operative, Day2, Day7
次要结局
- Physician feedback on catheter handling (insertion, torque, navigation, withdrawal).
研究者
Dr Vikas Gupta
Heart and General Hospital Jaipur