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

RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of "Real World" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease Mixed
• Intervention / Treatment: Procedure: Transcatheter aortic valve replacement

Detailed Description

Aortic stenosis is the most clinically important valvular heart disease in the elderly, with severe aortic stenosis accounting for about 3.4%-5% of elderly patients. Patients with chest pain, congestive heart failure, or syncope who do not undergo surgical intervention have a poor prognosis, with a 1-year mortality rate as high as 50%. However, the high surgical risk of surgical valve replacement for elderly patients with multiple underlying diseases limits the use of surgical valve replacement, and the prognosis of high-risk surgical patients is poor. The PARTNER series of studies and the US CoreValve high-risk studies confirm that perioperative and postoperative adverse events in patients undergoing TAVR in surgical high-risk patients are comparable to those in surgical valve replacement. With technological advances, the indications for TAVR have been expanded from surgical high-risk to low to moderate-risk populations. Based on the PARTNER 3 and Evolut Low Risk studies, FDA approved the use of TAVR to treat low surgical risk patients with symptomatic severe aortic stenosis. Recently, TAVR has also been expanded to patients with aortic valve regurgitation.

With a population of 1.4 billion, China has a large number of patients with aortic valve disease, but the TAVR program was launched in 2010. No large-scale TAVR studies are available to validate the efficacy and safety of TAVR in the Chinese population. The morphological characteristics of valves in our patients bring great challenges to the operation and application of TAVR. However, through the efforts of Chinese experts and scholars, TAVR technology in China has developed rapidly, and various domestic valves with independent intellectual property have been marketed, bringing new opportunities for the promotion and application of TAVR in China. Domestic valves have been designed for the Chinese aortic valve anatomy, which is theoretically more suitable for the Chinese population. However, the efficacy and safety of these valves still need to be further confirmed in large clinical studies.

This multi-center registry study aims to evaluate the safety and efficacy of all post-marketing transcatheter valves in Chinese patients with aortic valve disease mixed. Investigators will collect baseline and procedural data, and evaluate the short-, mid-, and long-term clinical outcomes of TAVR in a large real-world population.

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

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

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Ling Tao
      • Contact: Rutao Wang, M.D., Ph.D.; Phone Number: +86-15091095796; Email: rutaowang@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, acute kidney injury, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, vascular and access-related complications, structural cardiac complications, any other adverse events	30 days
Combined 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, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, any other adverse events	2 years, 3 years, 4 years
Combined 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, life-threatening or fatal bleeding, mild or greater prosthetic valve regurgitation, new permanent pacemaker implantation, conduction block and arrhythmia, structural valve deterioration, any other adverse events	5 years and 10 years
Rate of technical success	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 devicea or to a major vascular or access-related, or cardiac structural complication	at exit from procedure room
Rate of device success	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, peak velocity <3 m/s, Doppler velocity index >_0.25, and less than moderate aortic regurgitation)	discharge or 30 days

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): October 30, 2023
• Primary Completion (Estimated): November 1, 2033
• Study Completion (Estimated): January 1, 2034

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: February 11, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: TAVR; Aortic Valve Disease; Real world
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: RECORD TAVR REGISTRY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No