Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients

NCT06257043 | Recruiting DMC

• 1 other identifier: RECORD TAVR REGISTRY
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective multi-center, observational registry in China is to collect clinical baseline, procedural, and follow-up data of all patients treated with TAVR in China and to evaluate short-, mid-, and long-term clinical outcome data of all post-marketing transcatheter valves. Each center will collect baseline and procedural data as well as clinical outcomes for up to 10 years.

Conditions

Aortic Valve Disease Mixed

Keywords

Aortic Valve Disease; Real world; TAVR

Outcome Measures

Primary Outcomes (1)

• Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)

  Composed by all-cause mortality, all strokes, any hospitalization, myocardial infarction

  1 year

Secondary Outcomes (5)

• Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)

  30 days

• Rate of technical success

  at exit from procedure room

• Rate of device success

  discharge or 30 days

• Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)

  2 years, 3 years, 4 years

• Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)

  5 years and 10 years

Interventions

Transcatheter aortic valve replacement PROCEDURE

A total of 3000 consecutive patients with aortic valve disease undergoing TAVR will be enrolled at 30-50 centers. The devices used will be all post-market transcatheter aortic valves approved for use in China. Clinical follow-up will be conducted in the periprocedural and after aortic valve implantation at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years

Also known as: Transcatheter aortic valve implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with aortic valve disease who are evaluated by the cardiac team for TAVR treatment

You may qualify if:

• Patients with aortic valve disease are evaluated by the cardiac team and indicate TAVR therapy
• Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form

You may not qualify if:

• Patients with aortic valve disease who have been evaluated by a cardiac team as unsuitable for TAVR
• Patients who cannot tolerate the materials or medications associated with this study
• Women who are pregnant or breastfeeding
• Patients who participated in a clinical trial of another drug or medical device before enrollment

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ling Tao

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

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

Ruining Zhang, BSc

CONTACT

+86-15802990370; ruining-zhang@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology, Director of the department of Cardiology

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: February 13, 2024
• Study Start: October 30, 2023
• Primary Completion (Estimated): November 1, 2033
• Study Completion (Estimated): January 1, 2034
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)