Pacemaker DDDNCT04383392
QoL Between CIEDs With and Without Rate Adaptive Pacing
A study testing Rate adaptive pacing in people with Pacemaker DDD and Quality of Life, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Pacemaker DDD, Quality of Life
- What is being tested?
- Rate adaptive pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2016to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sick sinus syndrome for permanent dual-chamber pacing
- pacemakers are implanted for ≥30 days with no complications.
Who cannot join
- (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 locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-over Randomized Controlled Trial of Quality of Life Between Cardiovascular Implantable Electronic Device With and Without Rate Adaptive Pacing
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
- Being tested
- Rate adaptive pacing
- Keywords
- rate adaptive, pacemaker, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate adaptive pacingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Rate adaptive pacing | Experimental | Turn on Rate adaptive pacing Receives: Device: Rate adaptive pacing |
| No Rate adaptive pacing | Active comparator | Turn off Rate adaptive pacing Receives: Device: Rate adaptive pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Form 36 Questionnaire
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).
Measured: 3 months
Secondary outcomes (2)
6 minute walking test
Measured: 3 months
NYHA functional class
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Feb 2016
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DDDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383392
- Sponsor's protocol ID
- NTUHHsin-Chu
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-over Randomized Controlled Trial of Quality of Life Between Cardiovascular Implantable Electronic Device With and Without Rate Adaptive Pacing
- ClinicalTrials.gov ID
- NCT04383392
- Acronym / sponsor ID
- NTUHHsin-Chu
- Conditions
- Pacemaker DDD, Quality of Life
- Keywords
- rate adaptive, pacemaker, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rate adaptive pacing | Experimental | Device: Rate adaptive pacingTurn on Rate adaptive pacing |
| No Rate adaptive pacing | Active comparator | Device: Rate adaptive pacingTurn off Rate adaptive pacing |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sick sinus syndrome for permanent dual-chamber pacing
- pacemakers are implanted for ≥30 days with no complications.
Key exclusion criteria (4 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rate adaptive pacingRate-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. | Device | No Rate adaptive pacing, Rate adaptive pacing |
Primary outcome
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).
2 secondary outcomes
6 minute walking test
Time frame: 3 months
NYHA functional class
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rate adaptive pacing in people with Pacemaker DDD and Quality of Life, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form 36 Questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.