Allometric-Pace Study

Sinus Node Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766462
• Other study ID #: Allometric-Pace Study
• Status: Recruiting
• Start date: March 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: Simon Cao, PhD
• Phone: +8613918635345
• Email: simon.cao[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

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

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Life quality measurement	SF-36 questionnaire score will be used as the criteria.	Within three months after the surgery
Secondary	Cardiac functional changes	LVEF will be measured	Within three months after the surgery
Secondary	To assess the correlation of elevated blood pressure and bradycardia.	24 hour ambulatory blood pressure will be measured.	Within three months after the surgery