GLOBAL DEBUT
The SEASTAR Trial
DOCS VALVE™: World's First Pre-market Randomized Controlled Trial (RCT) for Aortic Regurgitation TAVR
Advancing the New Standard in Aortic Regurgitation Treatment
Clinical History & Roadmap
Early stage
Phase I
FIM
Nov 2024
RCT Initiation
Nov 2025
London PCR valves
May 2026
Enrollment Completion
2026-2027
SEASTAR Trial Design
Patients with Symptomatic Severe AR
Informed Consent
Inclusion and Exclusion Criteria Assessment
Eligible for Enrollment
Screen Failure
Randomization 1:1(N=164)
Experimental:
TAVR (DOCS VALVE™)
Control:
SAVR (Bovine Valve Prosthesis)
Follow-up: 1-week, 30-Day, 6-Month, 1-Year
Adverse Event Reporting
PRIMARY ENDPOINT
● All-cause mortality at 1 year post-procedure
SECONDARY ENDPOINTS
● Device & Procedural Success Rates
● Device deliverability and deployment performance
● Post-operative cardiac & prosthetic valve function
PRIMARY ENDPOINT
● Incidence of Adverse Events (MAE)
● Valve-related complications (VARC-3 Criteria)
Global Academic Spotlight
London PCR Valves 2025
Key Highlights Presented:
● SEASTAR Trial protocol overview and statistical rationale
● Single-center baseline characteristics, early outcomes and safety profile
● Case sharing: representative challenging AR TAVR cases
London PCR Valves 2025, November 2025
Clinical Excellence in Action: 2025 Live Case Series
The 6th China Structural Heart Disease Conference, April 2025
The 12th Wuhan International Cardiovascular Disease Conference, July 2025
China Valve (Hangzhou) 2025, April 2025
China Structural Heart Week 2025, October 2025
Advancing Global Standards
With the SEASTAR Trial enrollment concluding in May 2026, Vickor Medical continues to build a robust foundation of clinical evidence. Our commitment extends beyond regional boundaries, as we initiate global feasibility studies to bring the DOCS VALVE™ system to patients and clinicians worldwide.
STATUS: GLOBAL CLINICAL FEASIBILITY IN PROGRESS
Messages
Get in touch with us to learn more about DOCS VALVE™ clinical studies and first-in-human opportunities in the U.S. and Europe.”
DOCS VALVE™ Transcatheter System
Advancing a New Standard in Aortic Regurgitation Treatment
DOCS VALVE™ is purpose-built for native aortic regurgitation and designed to treat both routine and complex anatomies with confidence. Its advanced anchoring mechanism, enhanced coaxial delivery system, and stable deployment design enable precise positioning, procedural simplicity, and reliable performance across a broad range of patients.
©2023 Wuhan Vickor Medical Technology Co., Ltd.
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