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Allometric-Pace Study | Clinical Trials | Clareo Health

COMPLETED

Allometric-Pace Study

Utilization of Personalized Pacing to Improve Quality of Life in Sinus Node Dysfunction Patients

NCT05766462•Medtronic Cardiac Rhythm and Heart Failure

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. 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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (3)

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

West China Hospital

Chengdu, Sichuan, China

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Key Dates

Start Date

March 20, 2023

Primary Completion Date

November 4, 2024

Completion Date

January 31, 2025

Last Updated

February 7, 2025

Enrollment

ACTUAL participants

Conditions

Sinus Node Dysfunction

Interventions

Pacemaker lower rate setting

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Allometric-Pace Study

Inclusion Criteria

Exclusion Criteria

The Fluoroless-CSP Trial Using Electroanatomic Mapping

Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

ImageReady(TM) MR Conditional Pacing System Clinical Study

Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement

Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease