NCT05694572招募中不适用
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
MicroPort CRM1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2023年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Chronic complication free rate of MicroPort CRM market-released system
研究概览
简要总结
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
详细描述
PIANO Post Market Surveillance (PMS) investigation will cover MicroPort CRM systems CE- market and released since 2018.
Continuous monitoring of MicroPort CRM market-released systems will also enable to:
- confirm the safety and performance of the device throughout the study duration
- identify previously unknown side-effects and monitoring the identified side-effects and contraindications,
- identify and analyse emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio
- identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:
- •Subject implanted with one of the following MicroPort CRM market-released system:
- •ENO, TEO, OTO, ALIZEA, BOREA, or CELEA PM single chamber (SR) or dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead
- •ULYS, EDIS ICD single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional.
- •GALI CRT-D implanted in combination with an INVICTA defibrillation lead. Additional NAVIGO left ventricular pacing lead is optional.
- •GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular or a SONRTIP atrial pacing lead.
- •Future generation of market approved MicroPort CRM PM, ICD or CRT-D device associated with existing or future generation of MicroPort CRM lead
- •Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
- •Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
- •Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation
排除标准
- •Subjects who meet any of the following criteria are not eligible to be enrolled in the study:
- •Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
- •Life expectancy less than 1 year
- •Currently enrolled in an active study of MicroPort CRM
结局指标
主要结局
Chronic complication free rate of MicroPort CRM market-released system
时间窗: Through study duration, an average of 5 years
Complications are defined as device-related reinterventions or deaths
次要结局
- Acute complication free rate(Up to 3 months post-implant)
- Overall complication free rate(Through study duration, an average of 5 years)
- Annual complication free rate(Through study duration, an average of 1 year)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH StudyAortic Valve StenosisNCT04414865Shanghai MicroPort CardioFlow Medtech Co., Ltd.100
撤回
不适用
Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral StemJoint DiseasesNCT04615039MicroPort Orthopedics Inc.
已完成
不适用
A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese SubjectsCervical Intraepithelial NeoplasiaNCT03438006GlaxoSmithKline3,016
已完成
不适用
PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL RegistryAortic StenosisNCT02987894Symetis SA500
招募中
不适用
Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve BioprothesisAortic Valve DiseaseArtificial Heart ValvesNCT05998694Closed Joint-Stock Company NeoCor2,000