A Cross-over Randomized Controlled Trial of Quality of Life Between Cardiovascular Implantable Electronic Device With and Without Rate Adaptive Pacing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pacemaker DDD
- Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Short-Form 36 Questionnaire
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •sick sinus syndrome for permanent dual-chamber pacing
- •pacemakers are implanted for ≥30 days with no complications.
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Short-Form 36 Questionnaire
Time Frame: 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).
Secondary Outcomes
- 6 minute walking test(3 months)
- NYHA functional class(3 months)