Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

Recruiting N/A Interventional Study
Aortic Valve Stenosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
65 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
73 (estimated)
Sponsor
Shanghai NewMed Medical Co., Ltd. · Industry
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About This Trial

The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 65 years ; 2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\<1.0cm², or AVA \<0.5cm² /m²); 3. Cardiac …
Contacts

Chunyang Wang

(86)-21-20788668

wang_chunyang@newmed.cn

CONTACT

Xuyang Xie

(86)-21-20788668

CONTACT