QoL Between CIEDs With and Without Rate Adaptive Pacing

Not Applicable

• Conditions: Pacemaker DDD; Quality of Life
• Interventions: Device: Rate adaptive pacing

• Registration Number: NCT04383392
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-12
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-26
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rate adaptive pacing	Rate adaptive pacing	Turn on Rate adaptive pacing
No Rate adaptive pacing	Rate adaptive pacing	Turn off Rate adaptive pacing

Primary Outcome Measures

Name	Time	Method
Short-Form 36 Questionnaire	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 Outcome Measures

Name	Time	Method
6 minute walking test	3 months
NYHA functional class	3 months

Trial Locations

Locations (1)

National Taiwan University Hospital Hsinchu Branch; 🇨🇳 Hsinchu, Taiwan