Surgical Treatments of Tricuspid Valve Regurgitation Afte... | NCT06554119

Studies
Surgical Treatments of Tricuspid Valve Regurgitation After Cardiac Surgery

NCT06554119

Sponsor

Guangdong Provincial People's Hospital

Status

Recruiting

Last Update Posted

Aug 15, 2024Actual

Enrollment

375Estimated

Phase

Not provided

Conditions

Tricuspid Valve Regurgitation; Complications, Longterm Outcome

Interventions

Huanlei Huang

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999Actual

Primary Completion Date

Jan 2025Estimated

Completion Date

Jan 2025Estimated

First Submitted Date

Aug 13, 2024

First Submission Date that Met QC Criteria

Aug 13, 2024

First Posted Date

Aug 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2024

Last Update Posted Date

Aug 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Huanlei Huang, PhD, MD. pHD, Guangdong Provincial People's HospitalPrincipal Investigator

Lead Sponsor

Guangdong Provincial People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to present our center's experience in managing postoperative tricuspid valve regurgitation over the past 25years and to analyze the outcomes of these surgical treatments.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

375Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TVR		tricuspid valve replacement group，	Procedure: Huanlei Huang
TVP		tricuspid valvuloplasty group	Procedure: Huanlei Huang

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Huanlei Huang	Procedure	tricuspid valve replacement or plasty	TVP TVR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
death rate	perioperative and longterm	1999-01 - 2025-01
complications	perioperative and longterm complications	1999-01 - 2025-01

Secondary Outcomes

Measure	Description	Time Frame
redo of tricuspid valve	redo of tricuspid valve during the follow-up	1999-01 - 2025-01

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:patients who underwent surgical treatment from 1999 to 2023 for tricuspid valve disease following cardiac surgery

Exclusion Criteria: age <16，severe tricuspid regurgitation secondary to primary pulmonary hypertension, and those with substantial missing case data.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients who underwent surgical treatment from 1999 to 2023 for tricuspid valve disease following cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huanlei Huang	Contact	02083827812-10410		hhuanlei@hotmail.com
Yingjie Ke	Contact	02083827812-10410		570706155@qq.com

Overall Officials

Name	Affiliation	Role
Huanlei Huang	Guangdong Provincial People's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University	Recruiting	Guangzhou	Guangdong	510080	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Huanlei HuangContact02083827812hhuanlei@hotmail.com
Yingjie KeSub-Investigator
Shuo XiaoSub-Investigator
Zhaolong ZhangSub-Investigator
Lishan ZhongSub-Investigator
Linbin HuaSub-Investigator
Shanwen PangSub-Investigator
Junfei ZhaoSub-Investigator
Qiuji WangSub-Investigator
Huanlei HuangPrincipal Investigator