Cingularbio® Heart Valve Clincial Study

Shanghai Cingularbio Co. Ltd197 enrolled

Overview

This study aimed to evaluate the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement in Chinese population

single arm, 12 month follow up, mutile center, to assess the safety and effectiveness of Cingularbio® heart valve in Aortic Valve Replacement and Mitral Valve Replacement patients

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

197

Conditions

Diseases of Mitral and Aortic Valves

Interventions

Cingularbio® Aortic valve replacementDEVICE

the patients will be replaced by Cingularbio heart valve

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

The inclusion criteria were as follows: 1) patient who had heart valve disease requiring a surgical replacement as indicated in the preoperative evaluation; 2) patient aged between 60-85 years; 3) patient whose preoperative heart function less than NYHA functional class IV; 4) patient who signed the informed consent before surgery; 5) patient who agrees to finish the follow-up. The exclusion criteria were as follows: 1) patient with prior valve replacement; 2) patient who requires concomitant tricuspid or pulmonary valve replacement; 3) patient who requires concomitant coronary artery bypass graft surgery; 4) patient with active infective endocarditis or drug abuse; 5) patient whose life time expectancy less than 12 months; 6) patient who was unable to follow anticoagulation treatment.

Locations (5)

Cardiale Heelkunde

Leuven, Belgium

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Klinika Kardiochirurgii

Katowice, Poland

Klinika Kardiochirurgii

Krakow, Poland

Klinika Kardiochirurgii

Outcomes

Primary Outcomes

device related adverse valve events

device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak

Time frame: 12 month

Secondary Outcomes

rate of procedural success

device implant success

Time frame: post-operative

the difference between baseline and 1 year in Effective orifice area (EOA)

the difference between baseline and 1 year in Effective orifice area (EOA) in echocardiographic hemodynamic

Time frame: 1year

the difference between baseline and 1 year in pressure gradient (PG)

the difference between baseline and 1 year in pressure gradient (PG) in echocardiographic hemodynamic

Time frame: 1year

the difference between baseline and 1 year in Peak aortic valve velocity

the difference between baseline and 1 year in Peak aortic valve velocity in echocardiographic hemodynamic

Time frame: 1year

improvement in NYHA functional class

the NYHA score between baseline and 1 year

Time frame: 1year

mortality

the mortality rate at 1 year

Time frame: 1 year

structural valve deterioration

the SVD rate at 1 year

Time frame: 1 year

Data from ClinicalTrials.gov

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