Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker

Bradycardia Clinical Trial

— MICRA-SYNK  

Official title:

Effect of Different Pacing Sites on Cardiac Synchronization and Tricuspid Regurgitation After Leadless Pacemaker Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817695
• Other study ID #: MICRA-SYNK-001
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2022
• Source: First People's Hospital of Hangzhou
• Contact: Yi zhou XU
• Phone: +8657156005600
• Email: mage0311[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site

Description:

Right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. Pacing at various sites had different effects on synchrony and tricuspid regurgitation. This study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. Ultrasound and ECG parameter indices are applied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

patients consent to LP implantation surgery

Exclusion Criteria:

1. Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava;

2. Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system;

3. Patients with myocardial infarction;

4. Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves;

5. cannot understand or are unwilling to give informed consent.

Related Conditions & MeSH terms

• Bradycardia
• Tricuspid Valve Insufficiency

Intervention

Device:
• Leadless pacemaker
To observe the effect of pacemaker implantation at different sites on cardiac synchronization and tricuspid regurgitation

Locations

Country	Name	City	State
China	Yi zhou XU	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou	Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of cardiac electrical synchrony	the QRS duration after pacing	1 month
Primary	The evaluation of cardiac mechanical synchrony	?Synchronization analysis between left and right ventricles: interventricular mechanical delay (IVMD) in millisecond.; ?Left ventricle synchrony analysis: septal-to-posterior wall motion delay (SPWMD) in millisecond,left pre-ejection interval(LPEI) in millisecond.	1 month
Secondary	Age may affect synchronization	Age in years	1 month
Secondary	BMI may affect synchronization	BMI in kg/m^2	1 month
Secondary	Blood pressure may affect synchronization	Systolic and diastolic blood pressure in mmHg	1 month
Secondary	The pacemaker sensing may affect synchronization	pacemaker sensing in millivolt	1 month
Secondary	The pacemaker lead impedance may affect synchronization	lead impedance in ohm	1 month