Long-term Prognosis and Valve Durability of TAVR

NCT06379386 | Recruiting

• 1 other identifier: TRACE TAVR Registry
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Valve Stenosis and Insufficiency

Keywords

Aortic Valve Disease; TAVR; Prognosis; Valve durability

Outcome Measures

Primary Outcomes (2)

• All-casuse mortality

  All-casuse mortality including cardiac death and non-cardiac death

  5 years

• Valve-related long-term clinical efficacy

  * 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 Outcomes (5)

• Combined early safety and clinical efficacy outcomes

  30 days

• Rate of technical success

  at exit from procedure room

• Rate of device success

  discharge or 30 days

• Combined clinical efficacy outcomes

  5 years and 10 years

• Valve-related long-term clinical efficacy

  10 years

Interventions

Transcatheter aortic valve replacement PROCEDURE

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

Also known as: Transcatheter aortic valve implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients diagnosed with severe aortic valve regurgitation undergo evaluation by the Heart team and are eligible for TAVR therapy.
• \. Patients who understand the purpose of this study, agree to participate in the trial and sign the informed consent form
• \. Patients with aortic stenosis or aortic valve insufficiency who were evaluated by the Heart team and underwent TAVR therapy
• \. Patients who understand the purpose of the study, agree to participate in the trial and sign the informed consent form

You may not qualify if:

• \. Patients who cannot provide informed consent
• \. Patients who are participating in other clinical trials

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shannxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Ling Tao, M.D, Ph.D

  Xijing Hospital

  STUDY CHAIR

• Rutao Wang, M.D, Ph.D

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Rutao Wang, M.D, Ph.D

CONTACT

+86-15091095796; rutaowang@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology, Director of the department of Cardiology

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: January 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

CN (1)