Skip to main content
Clinical Trials/NCT05817695
NCT05817695
Recruiting
Not Applicable

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

First People's Hospital of Hangzhou1 site in 1 country40 target enrollmentMarch 1, 2022
ConditionsBradycardia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bradycardia
Sponsor
First People's Hospital of Hangzhou
Enrollment
40
Locations
1
Primary Endpoint
The evaluation of cardiac electrical synchrony
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
May 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
First People's Hospital of Hangzhou
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients consent to LP implantation surgery

Exclusion Criteria

  • Patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava;
  • Patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system;
  • Patients with myocardial infarction;
  • Patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves;
  • cannot understand or are unwilling to give informed consent.

Outcomes

Primary Outcomes

The evaluation of cardiac electrical synchrony

Time Frame: 1 month

the QRS duration after pacing

The evaluation of cardiac mechanical synchrony

Time Frame: 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 Outcomes

  • BMI may affect synchronization(1 month)
  • Blood pressure may affect synchronization(1 month)
  • The pacemaker sensing may affect synchronization(1 month)
  • Age may affect synchronization(1 month)
  • The pacemaker lead impedance may affect synchronization(1 month)

Study Sites (1)

Loading locations...

Similar Trials