Long-term Prognosis and Valve Durability of TAVR

NCT ID: NCT06379386

Last Updated: 2024-04-23

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2030-12-31

Brief Summary

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This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner.

Detailed Description

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Conditions

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Aortic Valve Stenosis and Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transcatheter aortic valve replacement

A total of 1000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled. Clinical follow-up will be conducted in the periprocedural and after TAVR at 1 month, 5 years, and 10 years

Intervention Type PROCEDURE

Other Intervention Names

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Transcatheter aortic valve implantation

Eligibility Criteria

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Inclusion Criteria

Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.

2\. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form

* 1\. Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
* 2\. Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form

Exclusion Criteria

* 1\. Patients who cannot provide informed consent
* 2\. Patients who are participating in other clinical trials
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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LingTao

Professor in Cardiology, Director of the department of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ling Tao, M.D, Ph.D

Role: STUDY_CHAIR

Xijing Hospital

Rutao Wang, M.D, Ph.D

Role: STUDY_CHAIR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shannxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rutao Wang, M.D, Ph.D

Role: CONTACT

+86-15091095796

Facility Contacts

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Rutao Wang, M.D., Ph.D.

Role: primary

+86-15091095796

Ruining Zhang, BSc

Role: backup

+86-15802990370

Other Identifiers

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TRACE TAVR Registry

Identifier Type: -

Identifier Source: org_study_id

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