Long-term Prognosis and Valve Durability of TAVR

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: Aortic Valve Stenosis and Insufficiency
• Intervention / Treatment: Procedure: Transcatheter aortic valve replacement

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• 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: Ruining Zhang, BSc; Phone Number: +86-15802990370; Email: ruining-zhang@qq.com
      • Contact: Rutao Wang, M.D., Ph.D.; Phone Number: +86-15091095796; Email: rutaowang@qq.com
      • Principal Investigator: Ling Tao, M.D., Ph.D.

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined early safety and clinical efficacy outcomes	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	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	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	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	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

• 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

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: Prognosis; TAVR; Aortic Valve Disease; Valve durability
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease
• 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