Long-term Prognosis and Valve Durability of TAVR

April 18, 2024 updated by: LingTao, Xijing Hospital

Long-term Prognosis and Valve Durability of Transcatheter Aortic Valve Replacement for Aortic Valve Disease: a Real-world, Prospective, Single-center, Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rutao Wang, M.D, Ph.D
  • Phone Number: +86-15091095796
  • Email: rutaowang@qq.com

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ling Tao, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with severe aortic stenosis or valve regurgitation undergo transcatheter aortic valve replacement (TAVR) following evaluation by a cardiac team.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-casuse mortality
Time Frame: 5 years
All-casuse mortality including cardiac death and non-cardiac death
5 years
Valve-related long-term clinical efficacy
Time Frame: 5 years
  • Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration
  • Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
  • Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined early safety and clinical efficacy outcomes
Time Frame: 30 days
Composed by all-cause mortality, all strokes, life-threatening or fatal bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities, conduction block and arrhythmia, surgery or intervention related to the device, any hospitalization, myocardial infarction, any other adverse events
30 days
Rate of technical success
Time Frame: at exit from procedure room
  • Freedom from mortality
  • Successful access, delivery of the device, and retrieval of the delivery system
  • Correct positioning of a single prosthetic heart valve into the proper anatomical location
  • Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
at exit from procedure room
Rate of device success
Time Frame: discharge or 30 days
  • Technical success
  • Freedom from mortality
  • Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
  • Intended performance of the valve (mean gradient<20mmHg, and less than moderate aortic regurgitation)
discharge or 30 days
Combined clinical efficacy outcomes
Time Frame: 5 years and 10 years
Combined clinical efficacy outcomes as composed by all-cause mortality (cardiac/non-cardiac), all strokes, any hospitalization
5 years and 10 years
Valve-related long-term clinical efficacy
Time Frame: 10 years
  • Freedom from bioprosthetic Valve Failure (defined as: Valve- related mortality OR Aortic valve re-operation/re-intervention OR Stage 3 hemodynamic valve deterioration
  • Freedom from stroke or peripheral embolism (presumably valve-related, after ruling out other non-valve aetiologies)
  • Freedom from VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns (e.g. clinically apparent leaflet thrombosis)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Ling Tao, M.D, Ph.D, Xijing Hospital
  • Study Chair: Rutao Wang, M.D, Ph.D, Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRACE TAVR Registry

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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