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QoL Between CIEDs With and Without Rate Adaptive Pacing

NCT04383392 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-05-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2020-06-01
Completion
2020-12-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04383392 on ClinicalTrials.gov