Sinus Node DysfunctionNCT05766462
Allometric-Pace Study
An observational study of Sinus Node Dysfunction, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in China.
Trial summary
The goal of this observational study is to improve quality of life in sinus node dysfunction patients by utilizing allometric lower rate pacing (or called personalized lower rate, PLR) in standard commercially available dual-chamber pacemakers. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sinus Node Dysfunction
- What is being tested?
- Pacemaker lower rate setting
- How many people
- 73 participants
- Where
- 3 sitesChina
- Study dates
- 20 Mar 2023to 31 Jan 2025
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The three sites locate in the north, west and south of China respectively and are all Tertiary A hospitals. This study will enroll 70 subjects who meet all the inclusion and exclusion criteria from the in-patients from the three hospitals.
Who may be able to join
- Patients are at age of equal to or more than 60 years old
- Patients have plan to implant dual-chamber pacemaker
- Resting sinus heart rate is equal or less than 60 bpm, or average heart rate detected through 24-hour dynamic electrocardiogram is equal or less than 60 bpm
- Patients have diagnosis of SND. If patients have both sinus node dysfunction and AV block, conduction system pacing shall be available
- Patients have a history of hypertension, two times of blood pressure measurements at office visit are equal to or more than 130 mmHg in systolic blood pressure, diastolic pressure is equal or less than 80 bpm
Who cannot join
- Patients have or possible concomitant a diagnosis of heart failure, either reduced EF or preserved EF
- Patients have persistent or chronic atrial fibrillation or clinically significant paroxysmal atrial fibrillation
- Previously diagnosed with a history of organic heart disease: including congenital heart disease, coronary heart disease, old myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, cardiac amyloidosis, long QT syndrome, etc.
- Patients have a known secondary cause of hypertension
- Patients have hospitalization of a hypertensive emergency in the previous year
- Patients have a history of renal disease or renal-artery diseases
Show all 11Show fewer
- Severe hepatic or renal dysfunction
- Active acute infection
- Patients cannot submit a signed informed consent form
- Patients are pregnant or plan to be pregnant during study period
- Patients participate in another study that will confound this study
Trial locations and contacts
3 sites in 1 country.
China3 sites
West China Hospital
Chengdu, Sichuan
The First People's Hospital of Yunnan Province
Kunming, Yunnan
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030000
About this study
Official title: Utilization of Personalized Pacing to Improve Quality of Life in Sinus Node Dysfunction Patients
The goal of this observational study is to improve quality of life in sinus node dysfunction patients by utilizing allometric lower rate pacing (or called personalized lower rate, PLR) in standard commercially available dual-chamber pacemakers.
The primary objective is to achieve a significant improvement in patients' quality of life with use of PLR pacing in comparison with the control group with nominal lower rate in patients with implanted dual-chamber pacemaker.
The secondary objectives are to assess cardiac functional changes in echocardiography of ventricular mechanical performance with a PLR pacing in comparison with the control group with nominal lower rate, and to assess the viability of using elevated blood pressure as a marker for undetected bradycardia and providing allometric rate to correct bradycardia-related increase in arterial systolic blood pressure.
- Conditions
- Sinus Node Dysfunction
- Being tested
- Pacemaker lower rate setting
- Medical subject headings
- Sick Sinus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker lower rate settingOther
Pacemaker lower rate is set by physician and may be adjusted according to the physician diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| PLR group | The pacemaker lower rate of PLR group will be set as 75 bpm and might be adjusted according to physician diagnosis based on patients situation. Receives: Other: Pacemaker lower rate setting | |
| control group | The pacemaker lower rate of control group will be set as 60 bpm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality measurement
SF-36 questionnaire score will be used as the criteria.
Measured: Within three months after the surgery
Secondary outcomes (2)
Cardiac functional changes
LVEF will be measured
Measured: Within three months after the surgery
To assess the correlation of elevated blood pressure and bradycardia.
24 hour ambulatory blood pressure will be measured.
Measured: Within three months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start20 Mar 2023
- Primary completion4 Nov 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sinus Node DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766462
- Sponsor's protocol ID
- Allometric-Pace Study
- Status last verified
- May 2024
- First submitted
- 20 Feb 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bassil G, Zarzoso M, Noujaim SF. Allometric scaling of electrical excitation and propagation in the mammalian heart. J Theor Biol. 2017 Apr 21;419:238-242. doi: 10.1016/j.jtbi.2016.09.024. Epub 2016 Sep 26.
PubMed 27686596Infeld M, Avram R, Wahlberg K, Silverman DN, Habel N, Lustgarten DL, Pletcher MJ, Olgin JE, Marcus GM, Meyer M. An approach towards individualized lower rate settings for pacemakers. Heart Rhythm O2. 2020 Dec;1(5):390-393. doi: 10.1016/j.hroo.2020.09.004. Epub 2020 Oct 6. No abstract available.
PubMed 33604585Infeld M, Wahlberg K, Cicero J, Meagher S, Habel N, Muthu Krishnan A, Silverman DN, Lustgarten DL, Meyer M. Personalized pacing for diastolic dysfunction and heart failure with preserved ejection fraction: Design and rationale for the myPACE randomized controlled trial. Heart Rhythm O2. 2021 Dec 7;3(1):109-116. doi: 10.1016/j.hroo.2021.11.015. eCollection 2022 Feb.
PubMed 35243443
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Personalized Pacing to Improve Quality of Life in Sinus Node Dysfunction Patients
- ClinicalTrials.gov ID
- NCT05766462
- Acronym / sponsor ID
- Allometric-Pace Study
- Conditions
- Sinus Node Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 13 Mar 2023 (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.
The goal of this observational study is to improve quality of life in sinus node dysfunction patients by utilizing allometric lower rate pacing (or called personalized lower rate, PLR) in standard commercially available dual-chamber pacemakers.
The primary objective is to achieve a significant improvement in patients' quality of life with use of PLR pacing in comparison with the control group with nominal lower rate in patients with implanted dual-chamber pacemaker.
The secondary objectives are to assess cardiac functional changes in echocardiography of ventricular mechanical performance with a PLR pacing in comparison with the control group with nominal lower rate, and to assess the viability of using elevated blood pressure as a marker for undetected bradycardia and providing allometric rate to correct bradycardia-related increase in arterial systolic blood pressure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLR group | – | Other: Pacemaker lower rate settingThe pacemaker lower rate of PLR group will be set as 75 bpm and might be adjusted according to physician diagnosis based on patients situation. |
| control group | – | –The pacemaker lower rate of control group will be set as 60 bpm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The three sites locate in the north, west and south of China respectively and are all Tertiary A hospitals. This study will enroll 70 subjects who meet all the inclusion and exclusion criteria from the in-patients from the three hospitals.
Key inclusion criteria (5 listed)
- Patients are at age of equal to or more than 60 years old
- Patients have plan to implant dual-chamber pacemaker
- Resting sinus heart rate is equal or less than 60 bpm, or average heart rate detected through 24-hour dynamic electrocardiogram is equal or less than 60 bpm
- Patients have diagnosis of SND. If patients have both sinus node dysfunction and AV block, conduction system pacing shall be available
- Patients have a history of hypertension, two times of blood pressure measurements at office visit are equal to or more than 130 mmHg in systolic blood pressure, diastolic pressure is equal or less than 80 bpm
Key exclusion criteria (11 listed)
- Patients have or possible concomitant a diagnosis of heart failure, either reduced EF or preserved EF
- Patients have persistent or chronic atrial fibrillation or clinically significant paroxysmal atrial fibrillation
- Previously diagnosed with a history of organic heart disease: including congenital heart disease, coronary heart disease, old myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, cardiac amyloidosis, long QT syndrome, etc.
- Patients have a known secondary cause of hypertension
- Patients have hospitalization of a hypertensive emergency in the previous year
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 |
|---|---|---|
| Pacemaker lower rate settingPacemaker lower rate is set by physician and may be adjusted according to the physician diagnosis. | Other | PLR group |
Primary outcome
Life quality measurement
Time frame: Within three months after the surgery
SF-36 questionnaire score will be used as the criteria.
2 secondary outcomes
Cardiac functional changes
Time frame: Within three months after the surgery
To assess the correlation of elevated blood pressure and bradycardia.
Time frame: Within three months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 27686596Bassil G, Zarzoso M, Noujaim SF. Allometric scaling of electrical excitation and propagation in the mammalian heart. J Theor Biol. 2017 Apr 21;419:238-242. doi: 10.1016/j.jtbi.2016.09.024. Epub 2016 Sep 26.
- Background: PubMed 33604585Infeld M, Avram R, Wahlberg K, Silverman DN, Habel N, Lustgarten DL, Pletcher MJ, Olgin JE, Marcus GM, Meyer M. An approach towards individualized lower rate settings for pacemakers. Heart Rhythm O2. 2020 Dec;1(5):390-393. doi: 10.1016/j.hroo.2020.09.004. Epub 2020 Oct 6. No abstract available.
- Background: PubMed 35243443Infeld M, Wahlberg K, Cicero J, Meagher S, Habel N, Muthu Krishnan A, Silverman DN, Lustgarten DL, Meyer M. Personalized pacing for diastolic dysfunction and heart failure with preserved ejection fraction: Design and rationale for the myPACE randomized controlled trial. Heart Rhythm O2. 2021 Dec 7;3(1):109-116. doi: 10.1016/j.hroo.2021.11.015. eCollection 2022 Feb.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinus Node Dysfunction, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in China.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Life quality measurement (time frame: Within three months after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05766462, which also lists 3 linked publications.
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 7 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.