AVEIR™ Leadless Pacemaker United Kingdom Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Percentage of patients without complications related to the device or implantation procedure.
研究概览
简要总结
This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the usual clinical settings within the UK National Health Service. In addition, the study will collect data to understand patient characteristics receiving this type of pacemaker.
详细描述
AVEIR™ stimulator (Abbott) obtained the approvals in July 2023 and started to be implanted in patients in Europe. As a leadless pacemaker, the AVEIR™ Leadless Pacemaker (LP) does not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter. AVEIR™ LP is intended to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target treatment group.
The purpose of this study is to understand long term safety and performance characteristic of this device. In addition, the study will collect anonymous clinical data and characteristics of the patients chosen to be implanted with AVEIR™ leadless pacemaker in routine clinical practice in approved centres across the UK.
Six hundred patients will be recruited in up to 15 centres during 2 years recruitment period. They will be followed up for 5 years after implantation of the leadless pacemaker. Investigators will record their age, sex, medical history, indications for receiving AVEIR™ and any complications related to the implantation procedure or the device itself. All the data will be collected in an anonymous format. Patients will be followed up according to the standard of care in the national health care system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patient is intended to receive or was treated with a (AVEIR™) Leadless Transcatheter Pacing
- •Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
- •Subject has been informed of the nature of the study, agrees to its provisions, and has provided a signed written informed consent, approved by the Regional Ethics Committee (REC).
排除标准
- •Subject is not suitable for implantation of the leadless device according to the expert opinion of their cardiologist.
- •Subject is not willing to comply with clinical investigation procedures and does not agree to return for all required follow-up visits, tests, and exams
- •Subject has been informed of the nature of the study, but does not agree to its provisions, and has not provided a signed written informed consent, approved by the REC
结局指标
主要结局
Percentage of patients without complications related to the device or implantation procedure.
时间窗: 5 years
Complications arising from the procedure or the device will be recorded to evaluate the success rate of the implantation.
Percentage of patients requiring re-intervention.
时间窗: 5 years
Replacement, explant, upgrade, or modification of the position of the device are considered re-interventions which will be used to evaluate safety of the device.
Stimulation threshold (V) in the therapeutic zone
时间窗: 5 years
Minimum current needed to stimulate the paced chamber.
Percentage of stimulation in the therapeutic zone
时间窗: 5 years
Percentage of paced vs non paced heart beats.
Impedance (Ohm) of R waves in the therapeutic zone
时间窗: 5 years
Physiological measure recorded by the device.
Amplitudes of R waves (mV) in the therapeutic zone
时间窗: 5 years
Physiological measure recorded by the device.
次要结局
- Age of patient (years) at AVEIR ™ leadless pacemaker implantation(5 years)
- Sex of patient at AVEIR ™ leadless pacemaker implantation(5 years)
- Medical history at AVEIR ™ leadless pacemaker implantation(5 years)
- Indications for AVEIR ™ leadless pacemaker implantation(5 years)