Clinical trial NCT06257043: Safety and Efficacy of Post-marketing Transcatheter Aortic Valves in "Real World" Chinese Patients
Official title: RECORD TAVR REGISTRY: Prospective, Multi-Center Registry of "Real World" Chinese Patients Undergoing Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Disease Mixed
Keywords: Aortic Valve Disease
Real world
TAVR
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with aortic valve disease who are evaluated by the cardiac team for TAVR treatment

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
timeFrame: 1 year
Secondary outcomes:
measure: Combined early safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
timeFrame: 30 days
measure: Rate of technical success
timeFrame: at exit from procedure room
measure: Rate of device success
timeFrame: discharge or 30 days
measure: Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
timeFrame: 2 years, 3 years, 4 years
measure: Combined safety and clinical efficacy outcomes as defined by the Valve Academic Research Consortium-3 (VARC-3)
timeFrame: 5 years and 10 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, M.D, Ph.D
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Rutao Wang, M.D, Ph.D
role: STUDY_CHAIR
References: