NCT04383392

QoL Between CIEDs With and Without Rate Adaptive Pacing

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pacemaker DDD
• Quality of Life

Interventions

Type	Name	Description
DEVICE	Rate adaptive pacing	Rate-adaptive pacing is a function of permanent pacemaker to accelerate patients' heart rate when they are walking, stair climbing, running or carrying on intensive physical activity. Appropriately, the function is similar to human's electrophysiology of sinus node but it may be difficult to replace sinus node's function totally. For example, the acceleration or deceleration slope when exercise beginning or cessation is not always the same or consistent in different patients and different time.

Timeline

• Start date: 2016-02-01
• Primary completion: 2020-06-01
• Completion: 2020-12-01
• First posted: 2020-05-12
• Last updated: 2020-05-26

Locations

1 site across 1 country: Taiwan