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RecruitingNot ApplicableNCT07035847

Transaxillary TAVR With Solely Echocardiography Guidance

Transaxillary Transcatheter Aortic Valve Replacement With Pure Echocardiography Guidance

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Enrollment

20 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Aortic Stenosis

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).

Eligibility

Inclusion Criteria2

  • 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

Exclusion Criteria4

  • 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.

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Interventions

PROCEDUREEchocardiography guided TAVR

Echocardiography guided TAVR

Locations(1)

Fuwai Hospital

Beijing, Beijing Municipality, China

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NCT07035847

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