TAVR With Echocardiography Guidance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Aortic Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Echo guided TAVR

Patients received Echocardiography guided TAVR

Group Type EXPERIMENTAL

Echocardiography guided TAVR

Intervention Type PROCEDURE

Echocardiography guided TAVR

Interventions

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Echocardiography guided TAVR

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No