Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
73 participants
OBSERVATIONAL
2023-03-20
2025-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Pacemaker lower rate setting
Pacemaker lower rate is set by physician and may be adjusted according to the physician diagnosis.
control group
The pacemaker lower rate of control group will be set as 60 bpm.
No interventions assigned to this group
Interventions
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Pacemaker lower rate setting
Pacemaker lower rate is set by physician and may be adjusted according to the physician diagnosis.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
West China Hospital
Chengdu, Sichuan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Countries
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References
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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.
Infeld 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.
Infeld 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.
Other Identifiers
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Allometric-Pace Study
Identifier Type: -
Identifier Source: org_study_id
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