Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257043
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-12-21
Brief Title:
Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in Real World Chinese Patients
Sponsor:
Xijing Hospital
Organization:
Xijing Hospital
Study Overview
Official Title:
RECORD TAVR REGISTRY Prospective Multi-Center Registry of Real World Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Aortic stenosis is the most clinically important valvular heart disease in the elderly with severe aortic stenosis accounting for about 34-5 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 14 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
With a population of 14 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None