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QoL Between CIEDs With and Without Rate Adaptive Pacing

N

National Taiwan University Hospital Hsin-Chu Branch

Status

Unknown

Conditions

Quality of Life
Pacemaker DDD

Treatments

Device: Rate adaptive pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT04383392
NTUHHsin-Chu

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

All

Ages

20 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

74 participants in 2 patient groups

Rate adaptive pacing
Experimental group
Description:
Turn on Rate adaptive pacing
Treatment:
Device: Rate adaptive pacing
No Rate adaptive pacing
Active Comparator group
Description:
Turn off Rate adaptive pacing
Treatment:
Device: Rate adaptive pacing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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