Allometric-Pace Study

NCT05766462 | Completed

• 1 other identifier: Allometric-Pace Study
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sinus Node Dysfunction

Outcome Measures

Primary Outcomes (1)

• Life quality measurement

  SF-36 questionnaire score will be used as the criteria.

  Within three months after the surgery

Secondary Outcomes (2)

• Cardiac functional changes

  Within three months after the surgery

• To assess the correlation of elevated blood pressure and bradycardia.

  Within three months after the surgery

Study Arms (2)

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

control group

The pacemaker lower rate of control group will be set as 60 bpm.

Interventions

Pacemaker lower rate setting OTHER

Pacemaker lower rate is set by physician and may be adjusted according to the physician diagnosis.

PLR group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (3)

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 030000, China

Location

West China Hospital

Chengdu, Sichuan, China

Location

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Location

Related Publications (3)

• 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.

  PMID: 27686596 BACKGROUND

• 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.

  PMID: 33604585 BACKGROUND

• 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.

  PMID: 35243443 BACKGROUND

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 13, 2023
• Study Start: March 20, 2023
• Primary Completion: November 4, 2024
• Study Completion: January 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)