Allometric-Pace Study

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.

Study Overview

• Status: Completed
• Conditions: Sinus Node Dysfunction
• Intervention / Treatment: Other: Pacemaker lower rate setting

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Cardiovascular Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • The First People's Hospital of Yunnan Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life quality measurement	SF-36 questionnaire score will be used as the criteria.	Within three months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac functional changes	LVEF will be 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.	Within three months after the surgery

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): November 4, 2024
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Arrhythmia, Sinus; Sick Sinus Syndrome
• Other Study ID Numbers: Allometric-Pace Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No