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临床试验/NCT04383392
NCT04383392Unknown不适用

A Cross-over Randomized Controlled Trial of Quality of Life Between Cardiovascular Implantable Electronic Device With and Without Rate Adaptive Pacing

National Taiwan University Hospital Hsin-Chu Branch1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
74
试验地点
1
主要终点
Short-Form 36 Questionnaire

研究概览

简要总结

Clinical implantable electronic devices, such as permanent pacemaker, implantable cardioverter defibrillator and cardiac resynchronization therapy are used in current daily practice for patients with bradycardia, ventricular arrhythmia, or heart failure. The rapid progress of permanent pacemaker function is growing to replace human's degenerating electrophysiology of heart.

The ability of physical work is an important cornerstone of quality of life. In daily activities, rate response to higher rate is importance for patients with bradycardia who can not accelerate their heart rate. And rate-adapting pacing of permanent pacemaker is a design to increase heart rate pacing according to physical activity or emotional activity. Patients with rate-adaptive pacing will get more cardiac output and overcome the physical activity such as stair climbing. But there are few studies to evaluate whether the rate-adaptive pacing of permanent pacemaker will improve the quality of life in people with bradycardia. The aim of this study is to compare turn-on with turn-off this function (DDDR vs DDD) whether rate-adaptive pacing will improve quality of life in patients with permanent pacemakers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sick sinus syndrome for permanent dual-chamber pacing
  • pacemakers are implanted for ≥30 days with no complications.

排除标准

  • (1) patient or legal representative could not provide written informed consent
  • (2) unwillingness or inability to return for follow-up visits or reason to believe that adherence to follow-up visits wound be irregular,
  • (3) current or scheduled enrollment in other, conflicting studies,
  • (4) concomitant disease or other medical condition likely to result in death within 6 months, and

结局指标

主要结局

Short-Form 36 Questionnaire

时间窗: 3 months

The SF-36 questionnaire consists of eight health concepts (1) physical functioning, (2) role limitations due to physical health, (3) bodily pain, (4) general health perceptions, (5) vitality (energy/fatigue), (6) social functioning, (7) role limitations due to emotional health, (8) general mental health (psychological distress/wellbeing) which are expressed as a score on a 0-100 scale for each of the eight health concepts. The maximum score of 100 means no disability in five of the scales (Physical Functioning, Role Physical, Bodily Pain, Social Functioning, and Role Emotional) and indicates not the absence of disability, but the presence of a positive state of health in the other scales (General Health, Vitality and Mental Health).

次要结局

  • 6 minute walking test(3 months)
  • NYHA functional class(3 months)

研究者

发起方
National Taiwan University Hospital Hsin-Chu Branch
申办方类型
Other
责任方
Sponsor

研究点 (1)

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