TAVR With Echocardiography Guidance

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Enrolling

Conditions: Aortic Stenosis

Treatments: Procedure: Echocardiography guided TAVR

Study type: Interventional

Funder types: Other

Identifiers

NCT07035847

2025-0501

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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)
2. a history of malignancy or a high familial risk of cancer, with refusal to undergo contrast- or radiation-guided procedures
3. chronic kidney disease and refuse to receive contrast agents or radiation exposure.
4. suitable for Transaxillary TAVR

Exclusion criteria

1. required hybrid procedures or concomitant interventions on other cardiac malformations
2. inoperable due to extremely high surgical risk or severe comorbidities
3. untreated clinically significant (>70% obstruction) proximal vessel coronary vascular disease amenable to revascularization
4. previously undergone aortic valve replacement.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Echo guided TAVR

Experimental group

Description:

Patients received Echocardiography guided TAVR

Treatment:

Procedure: Echocardiography guided TAVR