BradycardiaNCT07589452
Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction
A study testing Personalized lower rate pacing and Standard lower rate pacing in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in China.
Trial summary
The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker. Enrolled patients will be randomized 1:1 into the control group and the allometric-pace group. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Personalized lower rate pacing and Standard lower rate pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years of age
- Planned implantation of a dual chamber pacemaker with physiological pacing
- Resting sinus heart rate ≤60 bpm, or average 24 hour Holter heart rate ≤60 bpm
- Documented history of hypertension or office systolic blood pressure ≥130 mmHg
Who cannot join
- Diagnosis of secondary hypertension
- Diagnosis of or possible concomitant heart failure, with ejection fraction ≤50%
- Paroxysmal, persistent, or permanent atrial fibrillation
- Status post CABG or PCI
- Structural heart disease
- Risk of ventricular tachyarrhythmia
Show all 11Show fewer
- Severe hepatic or renal dysfunction
- Active acute infection
- Inability to sign informed consent
- Pregnancy or planned pregnancy during the study period
- Enrollment in other clinical studies that may affect the objectives of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030024
Simon Dr. Cao, +86-17633919999, simon.cao@medtronic.com
About this study
The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker. Enrolled patients will be randomized 1:1 into the control group and the allometric-pace group. In the control group, the pacing lower rate will be set to the nominal 60 bpm post a dual-chamber pacemaker implantation as frequently used in clinical practice, while in the allometric-pace group, the pacing rate will be programmed at 75 bpm based on the estimation for Chinese population with a height of 165-170 cm (also called personalized lower rate) or based on the symptom-relief per clinical assessment by the study physicians. Each patient will undergo baseline assessments and 3-month follow-up visits. At the enrollment and office visits, each patient will undergo arterial blood pressure measurement, cardiac functional assessment and cerebral blood flow measurement. At the end of the study, the study physician will adjust pacing lower rate based on patients' conditions and clinical assessments. After the completion of the study, all patients will have regular device follow-up visit, usually 6-month interval or annually.
Each patient will receive the following major assessments: device performance and pacing percentages, ventricular diastolic function by doppler and echocardiography of LVEF, LVEDV, LVESV, stroke volume, cardiac output, arterial blood pressure measurements, cerebral blood flow by MRI or Echo (which one will be determined later by the study PIs), and Mini-Mental State Examination (MMSE).
- Conditions
- Bradycardia
- Being tested
- Personalized lower rate pacing, Standard lower rate pacing
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized lower rate pacingDevice
The intervention consists of programming the pacemaker lower rate to a personalized setting of 75 beats per minute (personalized lower rate, PLR), based on clinical assessment. The control condition uses the standard pacemaker lower rate programmed at 50-60 beats per minute. No additional procedures beyond routine clinical practice are introduced.
Standard lower rate pacingDevice
The control intervention consists of programming the pacemaker lower rate to the standard clinical setting of 50-60 beats per minute, according to routine clinical practice. No additional procedures or deviations from standard care are introduced.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Lower Rate Pacing Group (75 bpm) | Experimental | Participants in this group will receive dual-chamber pacemaker implantation per standard clinical practice. After implantation, the device lower rate will be programmed to a personalized pacing rate of 75 beats per minute according to the study protocol. Ventricular diastolic function, cerebral blood flow, cognitive function, and blood pressure will be assessed during follow-up. Receives: Device: Personalized lower rate pacing |
| Conventional Lower Rate Pacing Group (60 bpm) | Active comparator | Participants in this group will receive dual-chamber pacemaker implantation per standard clinical practice. After implantation, the device lower rate will be programmed to the conventional lower pacing rate of 60 beats per minute. Outcome assessments during follow-up will be identical to those in the personalized pacing group. Receives: Device: Standard lower rate pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ventricular Diastolic Function and Cerebral Blood Flow
In hypertensive patients with sinus node dysfunction treated with dual chamber pacemaker implantation, compared with the control group (pacemaker lower rate 50-60 bpm), to verify whether ventricular diastolic function and cerebral blood flow can be improved by personalized lower rate pacing (PLR) (75 bpm).
Measured: Baseline to 6 months post-implantation
Secondary outcomes (3)
Cardiac Structure and Function Assessment
To evaluate cardiovascular function using echocardiography and assess ventricular function, particularly diastolic function, using Doppler echocardiography.
Measured: Baseline to 6 months post-implantation
Cerebral Perfusion and Cognitive Function Assessment
To evaluate cerebral cortical blood distribution and white matter changes using magnetic resonance imaging (MRI), and to assess cognitive function using the Mini Mental State Examination (MMSE).
Measured: Baseline to 6 months post-implantation
Arterial Blood Pressure Assessment
To evaluate changes in arterial blood pressure using office blood pressure measurement and 24 hour ambulatory blood pressure monitoring.
Measured: Baseline to 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start14 May 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
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
- NCT07589452
- Sponsor's protocol ID
- Allometric-Cerebral Study
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Changes in 24-hour ambulatory systolic blood pressure following pacemaker implantation in patients with sinus node dysfunction. Presented at the APHRS 2025 Scientific Sessions; 2025; Poster presentation.
Meng L, Hou W, Chui J, Han R, Gelb AW. Cardiac Output and Cerebral Blood Flow: The Integrated Regulation of Brain Perfusion in Adult Humans. Anesthesiology. 2015 Nov;123(5):1198-208. doi: 10.1097/ALN.0000000000000872.
PubMed 26402848Meyer M, LeWinter MM. Heart Rate and Heart Failure With Preserved Ejection Fraction: Time to Slow beta-Blocker Use? Circ Heart Fail. 2019 Aug;12(8):e006213. doi: 10.1161/CIRCHEARTFAILURE.119.006213. Epub 2019 Aug 1. No abstract available.
PubMed 31525068Infeld M, et al. Allometric-Based Pacing Rate Improves Quality of Life in Bradycardia Patients. Presented at the HRS 2025 Scientific Sessions; 2025; Poster presentation.
Infeld M, et al. A novel method to classify left bundle branch block with far-field intracardiac electrograms. Presented at the HRS 2025 Scientific Sessions; 2025; Poster presentation.
Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320.
PubMed 36723919Infeld 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 33604585
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction
- ClinicalTrials.gov ID
- NCT07589452
- Acronym / sponsor ID
- Allometric-Cerebral Study
- Conditions
- Bradycardia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 15 May 2026 (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 study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker. Enrolled patients will be randomized 1:1 into the control group and the allometric-pace group. In the control group, the pacing lower rate will be set to the nominal 60 bpm post a dual-chamber pacemaker implantation as frequently used in clinical practice, while in the allometric-pace group, the pacing rate will be programmed at 75 bpm based on the estimation for Chinese population with a height of 165-170 cm (also called personalized lower rate) or based on the symptom-relief per clinical assessment by the study physicians. Each patient will undergo baseline assessments and 3-month follow-up visits. At the enrollment and office visits, each patient will undergo arterial blood pressure measurement, cardiac functional assessment and cerebral blood flow measurement. At the end of the study, the study physician will adjust pacing lower rate based on patients' conditions and clinical assessments. After the completion of the study, all patients will have regular device follow-up visit, usually 6-month interval or annually.
Each patient will receive the following major assessments: device performance and pacing percentages, ventricular diastolic function by doppler and echocardiography of LVEF, LVEDV, LVESV, stroke volume, cardiac output, arterial blood pressure measurements, cerebral blood flow by MRI or Echo (which one will be determined later by the study PIs), and Mini-Mental State Examination (MMSE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Lower Rate Pacing Group (75 bpm) | Experimental | Device: Personalized lower rate pacingParticipants in this group will receive dual-chamber pacemaker implantation per standard clinical practice. After implantation, the device lower rate will be programmed to a personalized pacing rate of 75 beats per minute according to the study protocol. Ventricular diastolic function, cerebral blood flow, cognitive function, and blood pressure will be assessed during follow-up. |
| Conventional Lower Rate Pacing Group (60 bpm) | Active comparator | Device: Standard lower rate pacingParticipants in this group will receive dual-chamber pacemaker implantation per standard clinical practice. After implantation, the device lower rate will be programmed to the conventional lower pacing rate of 60 beats per minute. Outcome assessments during follow-up will be identical to those in the personalized pacing group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- ≥65 years of age
- Planned implantation of a dual chamber pacemaker with physiological pacing
- Resting sinus heart rate ≤60 bpm, or average 24 hour Holter heart rate ≤60 bpm
- Documented history of hypertension or office systolic blood pressure ≥130 mmHg
Key exclusion criteria (11 listed)
- Diagnosis of secondary hypertension
- Diagnosis of or possible concomitant heart failure, with ejection fraction ≤50%
- Paroxysmal, persistent, or permanent atrial fibrillation
- Status post CABG or PCI
- Structural heart disease
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 |
|---|---|---|
| Personalized lower rate pacingThe intervention consists of programming the pacemaker lower rate to a personalized setting of 75 beats per minute (personalized lower rate, PLR), based on clinical assessment. The control condition uses the standard pacemaker lower rate programmed at 50-60 beats per minute. No additional procedures beyond routine clinical practice are introduced. | Device | Personalized Lower Rate Pacing Group (75 bpm) |
| Standard lower rate pacingThe control intervention consists of programming the pacemaker lower rate to the standard clinical setting of 50-60 beats per minute, according to routine clinical practice. No additional procedures or deviations from standard care are introduced. | Device | Conventional Lower Rate Pacing Group (60 bpm) |
Primary outcome
Change in Ventricular Diastolic Function and Cerebral Blood Flow
Time frame: Baseline to 6 months post-implantation
In hypertensive patients with sinus node dysfunction treated with dual chamber pacemaker implantation, compared with the control group (pacemaker lower rate 50-60 bpm), to verify whether ventricular diastolic function and cerebral blood flow can be improved by personalized lower rate pacing (PLR) (75 bpm).
3 secondary outcomes
Cardiac Structure and Function Assessment
Time frame: Baseline to 6 months post-implantation
Cerebral Perfusion and Cognitive Function Assessment
Time frame: Baseline to 6 months post-implantation
Arterial Blood Pressure Assessment
Time frame: Baseline to 6 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- BackgroundChanges in 24-hour ambulatory systolic blood pressure following pacemaker implantation in patients with sinus node dysfunction. Presented at the APHRS 2025 Scientific Sessions; 2025; Poster presentation.
- Background: PubMed 26402848Meng L, Hou W, Chui J, Han R, Gelb AW. Cardiac Output and Cerebral Blood Flow: The Integrated Regulation of Brain Perfusion in Adult Humans. Anesthesiology. 2015 Nov;123(5):1198-208. doi: 10.1097/ALN.0000000000000872.
- Background: PubMed 31525068Meyer M, LeWinter MM. Heart Rate and Heart Failure With Preserved Ejection Fraction: Time to Slow beta-Blocker Use? Circ Heart Fail. 2019 Aug;12(8):e006213. doi: 10.1161/CIRCHEARTFAILURE.119.006213. Epub 2019 Aug 1. No abstract available.
- BackgroundInfeld M, et al. Allometric-Based Pacing Rate Improves Quality of Life in Bradycardia Patients. Presented at the HRS 2025 Scientific Sessions; 2025; Poster presentation.
- BackgroundInfeld M, et al. A novel method to classify left bundle branch block with far-field intracardiac electrograms. Presented at the HRS 2025 Scientific Sessions; 2025; Poster presentation.
- Background: PubMed 36723919Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli A, Habel N, Krishnan AM, Silverman DN, LeWinter MM, Lustgarten DL, Meyer M. Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and Overt Heart Failure With Preserved Ejection Fraction: The myPACE Randomized Clinical Trial. JAMA Cardiol. 2023 Mar 1;8(3):213-221. doi: 10.1001/jamacardio.2022.5320.
- 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized lower rate pacing and Standard lower rate pacing in people with Bradycardia, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgiana Zou (+86 18918711140, georgiana.zou@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ventricular Diastolic Function and Cerebral Blood Flow (time frame: Baseline to 6 months post-implantation). 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 NCT07589452, which also lists 7 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 21 Sep 2026.