MICRA-SYNK: Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker

Sponsor

First People's Hospital of Hangzhou (Other)

Overall Status

Recruiting

CT.gov ID

NCT05817695

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bradycardia	Device: Leadless pacemaker

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 [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 31, 2023

Outcome Measures

Primary Outcome Measures

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

Age may affect synchronization [1 month]
Age in years
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
The pacemaker lead impedance may affect synchronization [1 month]
lead impedance in ohm

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yi zhou XU	Hangzhou	Zhejiang	China	310006

Sponsors and Collaborators

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

Investigators

Principal Investigator: Yi zhou XU, First People's Hospital of Hangzhou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First People's Hospital of Hangzhou

ClinicalTrials.gov Identifier:

NCT05817695

Other Study ID Numbers:

MICRA-SYNK-001

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by First People's Hospital of Hangzhou

Leadless pacing

Synchronization

Additional relevant MeSH terms:

Bradycardia

Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Apr 18, 2023