Cardiac Synchronization and Tricuspid Regurgitation With Leadless Pacemaker (MICRA-SYNK)

April 16, 2023 updated by: First People's Hospital of Hangzhou

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

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

Study Overview

Status

Recruiting

Conditions

Bradycardia

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yi zhou XU
Phone Number: +8657156005600
Email: mage0311@163.com

Study Locations

China
- Zhejiang
  - Hangzhou, Zhejiang, China, 310006
    - Recruiting
    - Yi zhou XU
    - Contact:
      
      Yi zhou XU
      
      Phone Number: +8657156005600
      
      Email: mage0311@163.com
    - Contact:
      
      Xiao-fei Gao
      
      Phone Number: +8657188952242
      
      Email: mage0311@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

patients consent to LP implantation surgery

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of cardiac electrical synchrony Time Frame: 1 month	the QRS duration after pacing	1 month
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age may affect synchronization Time Frame: 1 month	Age in years	1 month
BMI may affect synchronization Time Frame: 1 month	BMI in kg/m^2	1 month
Blood pressure may affect synchronization Time Frame: 1 month	Systolic and diastolic blood pressure in mmHg	1 month
The pacemaker sensing may affect synchronization Time Frame: 1 month	pacemaker sensing in millivolt	1 month
The pacemaker lead impedance may affect synchronization Time Frame: 1 month	lead impedance in ohm	1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)