Transaxillary TAVR With Solely Echocardiography Guidance
ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChinese Academy of Medical Sciences, Fuwai Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Echocardiography guided TAVR
Procedure/SurgeryEchocardiography guided TAVR
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Echo guided TAVRExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
30 days after interventionSponsors and contacts
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Source ClinicalTrials.gov