Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis

NCT ID: NCT05761821

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-12-31

Brief Summary

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To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.

Detailed Description

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In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.

Conditions

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Complication of Surgical Procedure Pacemaker Complication Pacemaker Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Leadless pacemaker

All enrolled patients were implanted with leadless pacemaker.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient received implantation of leadless pacemaker
* Patient agreed to join into this study and signed informed consent

Exclusion Criteria

* Age \< 18 years
* Ventricular septal defect
* History of mechanical tricuspid valve replacement
* History of inferior vena cava filter placement
* Pregnant or plan to be pregnant within 2 years
* Life expectancy \< 1 year
* Patient was included in other studies that could introduce bias into this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Yangxin Chen

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yangxin Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

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Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yangxin Chen, PhD

Role: CONTACT

+8602081332360

Qi Guo, MD

Role: CONTACT

+8602081332360

Facility Contacts

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Yangxin Chen, PhD

Role: primary

+8602081332360

Other Identifiers

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SYSKY-2023-056-01

Identifier Type: -

Identifier Source: org_study_id

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