Transaxillary TAVR With Solely Echocardiography Guidance
Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance
1 other identifier
interventional
20
1 country
1
Brief Summary
This study aims to evaluate the safety and feasibility of performing transaxillary transcatheter aortic valve replacement (TA TAVR) guided solely by echocardiography in patients with severe aortic stenosis (AS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
May 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 27, 2026
February 1, 2026
2.2 years
May 11, 2025
February 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Valve Academic Research Consortium-3
Outcomes were reported according to the VARC-3 criteria.Which include: Technical success: Evaluated immediately post-procedure (e.g., successful vascular access, device delivery, deployment, no immediate complications). Device success: Includes successful valve function with acceptable hemodynamics and positioning. Procedural success: Includes 30-day outcomes, combining technical/device success and absence of major complications.
30 days after intervention
Study Arms (1)
Echo guided TAVR
EXPERIMENTALPatients received Echocardiography guided TAVR
Interventions
Eligibility Criteria
You may qualify if:
- symptomatic severe AS determined by echocardiography and Doppler that requiring aortic valve replacement, defined as: mean gradient ≥40 mmHg, peak aortic velocity ≥4 m/s, and aortic valve area (AVA) ≤1 cm2 (or an indexed AVA ≤0.6 cm2/m2)
- suitable for Transaxillary TAVR
You may not qualify if:
- required hybrid procedures or concomitant interventions on other cardiac malformations
- inoperable due to extremely high surgical risk or severe comorbidities
- untreated clinically significant (\>70% obstruction) proximal vessel coronary vascular disease amenable to revascularization
- previously undergone aortic valve replacement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangbin Pan, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
- STUDY DIRECTOR
Xu Wang, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 11, 2025
First Posted
June 25, 2025
Study Start
October 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02