NCT02275637招募中不适用
Arrhythmias Detection in a Real World Population: the RHYTHM DETECT Registry
Fondazione IRCCS Policlinico San Matteo di Pavia12 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2014年9月1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
- 10,000
- 试验地点
- 12
- 主要终点
- Patients with ICD therapy (shock)
研究概览
简要总结
The study is a prospective multicenter registry. Consecutive patients with indications of implant / replacement or upgrade of implantable cardioverter defibrillator (ICD) will be enrolled.
The primary objective of the study is to determine the predictors of appropriate anti-tachycardia therapy (with shock) in a non-selected population of patients implanted with an ICD.
Secondary objectives of the study are:
- the incidence of anti-tachycardia therapies;
- the predictors of inappropriate therapy and onset of arrhythmia burden;
- the adherence to the current guidelines in the Italian clinical practice;
- the predictors of heart failure (HF) onset and response to cardiac resynchronization therapy (CRT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient implanted with a Subcutaneous (S)- Ventricular Chamber (VR)- Dual Chamber (DR) - or Cardiac Resynchronization Therapy (CRT) Defibrillator (this study will utilize all the market released CRT-D or VR/DR-ICD systems and leads)
- •Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent
- •Patient must be able to attend all required follow-up visits at the study center for at least 12 months
排除标准
- •Patient is participating in another clinical study that may have an impact on the study endpoints
- •Women who are pregnant or plan to become pregnant
结局指标
主要结局
Patients with ICD therapy (shock)
时间窗: 24 months
Clinical or instrumental parameters that could predict the appropriate ICD therapies
次要结局
- Patients with inappropriate shock therapy(24 months)
- Time to first ICD therapy(24 months)
- Predictors of onset and Atrial Fibrillation (AF) burden(24 months)
- Incidence of ICD therapies(24 months)
研究者
Maurizio Eugenio Landolina
EP and Pacing Laboratory Director
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (12)
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