An interventional study of Personalized lower rate pacing and Standard lower rate pacing in Bradycardia, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure (part of Medtronic) · Not applicable, Interventional, and Treatment
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).
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 240 studies on the registry; 4 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Personalized lower rate pacing
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.
Device: Standard lower rate pacing
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.
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.
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).
Time frame: Baseline to 6 months post-implantation
Cardiac Structure and Function Assessment
To evaluate cardiovascular function using echocardiography and assess ventricular function, particularly diastolic function, using Doppler echocardiography.
Time frame: 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).
Time frame: 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.
Time frame: Baseline to 6 months post-implantation
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for Jan 2028, 20 months after the start.
Of 36 industry-sponsored interventional studies with no phase under Bradycardia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's planned 20 months is above that.
Counting every sponsor, half of 83 studies reached it within 21 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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