Effect of Different Pacing Sites on Cardiac Synchronization and Tricuspid Regurgitation After Leadless Pacemaker Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The evaluation of cardiac electrical synchrony
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)