Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker

Recruiting

• Conditions: Bradycardia

• Registration Number: NCT05817695
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2022-12
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-04-16
• Last Update Submitted: 2023-04-16
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The evaluation of cardiac electrical synchrony	1 month	the QRS duration after pacing
The evaluation of cardiac mechanical synchrony	1 month	①Synchronization analysis between left and right ventricles: interventricular mechanical delay (IVMD) in millisecond.; ②Left ventricle synchrony analysis: septal-to-posterior wall motion delay (SPWMD) in millisecond，left pre-ejection interval(LPEI) in millisecond.

Secondary Outcome Measures

Name	Time	Method
BMI may affect synchronization	1 month	BMI in kg/m\^2
Blood pressure may affect synchronization	1 month	Systolic and diastolic blood pressure in mmHg
The pacemaker sensing may affect synchronization	1 month	pacemaker sensing in millivolt
Age may affect synchronization	1 month	Age in years
The pacemaker lead impedance may affect synchronization	1 month	lead impedance in ohm

Trial Locations

Locations (1)

Yi zhou XU; 🇨🇳 Hangzhou, Zhejiang, China