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Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05817695
Acronym
MICRA-SYNK
Enrollment
40
Registered
2023-04-18
Start date
2022-03-01
Completion date
2023-05-31
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia

Keywords

Leadless pacing, Synchronization

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.

Interventions

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

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
CollaboratorOTHER
First People's Hospital of Hangzhou
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The evaluation of cardiac electrical synchrony1 monththe QRS duration after pacing
The evaluation of cardiac mechanical synchrony1 month①Synchronization 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

MeasureTime frameDescription
Blood pressure may affect synchronization1 monthSystolic and diastolic blood pressure in mmHg
The pacemaker sensing may affect synchronization1 monthpacemaker sensing in millivolt
BMI may affect synchronization1 monthBMI in kg/m\^2
Age may affect synchronization1 monthAge in years
The pacemaker lead impedance may affect synchronization1 monthlead impedance in ohm

Countries

China

Contacts

Primary ContactYi zhou XU
mage0311@163.com+8657156005600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026