Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Phase II: incidence of pre-specified clinical and arrhythmic events
研究概览
简要总结
The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation.
详细描述
The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial designed in two phases.
The purpose of the study is to assess a short term (6 months follow-up - Phase 1) and a long term period (24 months follow-up - Phase 2), incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation. A previously implanted Reveal® XT device will be used to collect heart rhythm information.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with a history of at least one heart failure (HF) hospitalization (as defined in the European Society of Cardiology or American College of Cardiology/American Heart Association guidelines), emergency department (ED) visit, or urgent office visit necessitating intravenous (IV) diuretic or augmentation of oral diuretic, IV inotropic, or IV vasodilator or other HF parenteral therapy within 15 days prior to device implant
- •Subject has an implanted Reveal® XT device (less than 15 days post implant);
- •Ejection Fraction (EF) less than 40 percent
- •Patient with access to a telephone line
- •Patient or the patient's caregiver is willing and able to use the Medtronic CareLink® Network Monitor and to perform the required duties at home or has a family member or assistant perform those duties
- •Age greater than 18 years old
- •Patient is willing and able to comply with the Clinical Investigation plan and willing to remain available for follow-up visit, through study closure
- •Patient (or patient's legally authorized representative) is willing and able to sign and date the study Informed Consent
排除标准
- •New York Heart Association (NYHA) Class IV (chronic or ambulatory)
- •Planned or previous implant of implantable cardioverter-defibrillator or pacemaker device
- •Patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician
- •Severe chronic obstructive pulmonary disorder (COPD)
- •Chronic Atrial Fibrillation at time of enrollment
- •ST segment elevation at time of electrocardiogram
- •Cognitive disease
- •Pregnancy or childbearing potential and not on reliable contraceptive
- •Anticipated compliance problem or participation in another competitive trial
结局指标
主要结局
Phase II: incidence of pre-specified clinical and arrhythmic events
时间窗: implant to 24 months post-implant
In patients with low ejection fraction that are hospitalized for acute cardiac decompensation, the pre-specified events include: 1. Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant) 2. Arrhythmic events
Phase I: incidence of pre-specified clinical and arrhythmic events
时间窗: implant to 6 months post-implant
In patients with low ejection fraction that are hospitalized for acute cardiac decompensation, the pre-specified events include: 1. Cardiovascular mortality or unplanned cardiovascular hospitalizations (including hospitalizations that will be scheduled due to pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device implant) 2. Arrhythmic events
次要结局
- Phase II: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT(implant to 24 months post-implant)
- Phase I: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT(implant to 6 months post-implant)