TAVR for Aortic Valve Disease | NCT05439863

Studies
TAVR for Aortic Valve Disease

NCT05439863

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Recruiting

Last Update Posted

Nov 15, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Aortic Valve Disease

Interventions

transcatheter heart valve

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

Nov 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

Jul 1, 2022Actual

Primary Completion Date

Dec 30, 2032Estimated

Completion Date

Dec 30, 2037Estimated

First Submitted Date

May 27, 2022

First Submission Date that Met QC Criteria

Jun 26, 2022

First Posted Date

Jun 30, 2022Actual

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

Nov 13, 2024

Last Update Posted Date

Nov 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Junjie Zhang, Vice chief, Nanjing First Hospital, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing First Hospital, Nanjing Medical UniversityOTHER

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

Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement (SAVR). However, many different issues have emerged: TAVR in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after TAVR? TAVR in bicuspid aortic valve? TAVR in aortic regurgitation? etc. Hence, a prospective, multicenter database is created to provide the real-word data for these questions.

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

Yes

Target Follow-Up Duration

15 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAVR in aortic valve disease			Device: transcatheter heart valve

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcatheter heart valve	Device	patients with severe aortic valve disease underwent transcatheter heart valve	TAVR in aortic valve disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all-cause death during follow-up	all-cause death during 5-year follow-up	5 years

Secondary Outcomes

Measure	Description	Time Frame
cardiac death during follow-up	Cardiac death during 5-year follow-up	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of severe aortic stenosis or aortic regurgitation
Patients undergo transcatheter aortic valve replacement

Exclusion Criteria:

patients refuse the clinical follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients undergoing transcatheter aortic valve replacement due to severe aortic valve stenosis or regurgitation were eligible into this registry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun-Jie Zhang, MD	Contact	+86-25-52271350		jameszll@163.com
Jing Kan, MPH	Contact	+86-25-52271398		kanjingok@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing First Hospital	Recruiting	Nanjing	Jiangsu	210006	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000082862	Aortic Valve Disease

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided