NCT05817695

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

April 18, 2023

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

February 16, 2023

Last Update Submit

April 16, 2023

Conditions

Bradycardia

Keywords

Leadless pacingSynchronization

Outcome Measures

Primary Outcomes (2)

  • The evaluation of cardiac electrical synchrony

    the QRS duration after pacing

    1 month

  • The evaluation of cardiac mechanical synchrony

    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 Outcomes (5)

  • Age may affect synchronization

    1 month

  • BMI may affect synchronization

    1 month

  • Blood pressure may affect synchronization

    1 month

  • The pacemaker sensing may affect synchronization

    1 month

  • The pacemaker lead impedance may affect synchronization

    1 month

Interventions

Leadless pacemakerDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients consent to LP implantation surgery

You may qualify if:

  • patients consent to LP implantation surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yi zhou XU

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yi zhou XU

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi zhou XU

CONTACT

+8657156005600mage0311@163.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

April 18, 2023

Study Start

March 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 31, 2023

Last Updated

April 18, 2023

Record last verified: 2022-12

Locations

CN(1)