RecruitingNot ApplicableNCT06101888

Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)

A Prospective, Multicenter, Single-group Clinical Study to Evaluate the Safety and Efficacy of Peijia Medical Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Regurgitation

Sponsor

Peijia Medical Technology (Suzhou) Co., Ltd.

Enrollment

116 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

aortic regurgitation

Summary

To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called TaurusTrio™ Heart Valve System for people with aortic regurgitation. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETaurusTrio™ Heart Valve System

The TaurusTrio™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool.

Locations(19)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Fu Wai Hospital, Beijing, China

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

XiaMen Cardiovascular Hospital XiaMen University

Xiamen, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital, Southern Medical University

Guangdong, Guangzhou, China

The Second Affiliated Hospital of Harbin Medical University

Haerbin, Heilongjiang, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Wuhan Union Hospital, China

Wuhan, Hubei, China

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing First Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Namchang Umiversity

Nanchang, Jiangxi, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Xijing Hospital

Xian, Shanxi, China

West China Hospital

Chengdu, Sichuan, China

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital of Zhejiang

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06101888

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