Cingularbio® Heart Valve Clincial Study

Diseases of Mitral and Aortic Valves Clinical Trial

Official title:

A Prospective, Mutli-center, Open Lable, Single Arm Study to Evaluate the Safety and Effectiveness of Cingularbio® Heart Valve in Aortic/Mitral Valve Replacement Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02755220
• Other study ID #: XZBM-2015-01
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 2019

Study information

• Verified date: April 2020
• Source: Shanghai Cingularbio Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diseases of Mitral and Aortic Valves

Intervention

Device:
• Cingularbio® Aortic valve replacement
the patients will be replaced by Cingularbio heart valve

Locations

Country	Name	City	State
Belgium	Cardiale Heelkunde	Leuven
China	Zhongshan Hospital of Fudan University	Shanghai	Shanghai
Poland	Klinika Kardiochirurgii	Katowice
Poland	Klinika Kardiochirurgii	Kraków
Poland	Klinika Kardiochirurgii	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Cingularbio Co. Ltd

Countries where clinical trial is conducted

Belgium,  China,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	device related adverse valve events	device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak	12 month
Secondary	rate of procedural success	device implant success	post-operative
Secondary	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	1year
Secondary	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	1year
Secondary	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	1year
Secondary	improvement in NYHA functional class	the NYHA score between baseline and 1 year	1year
Secondary	mortality	the mortality rate at 1 year	1 year
Secondary	structural valve deterioration	the SVD rate at 1 year	1 year
Secondary	reoperation	the reoperation rate at 1 year	1 year
Secondary	valve-related adverse events	all valve related AEs (not primary endpoint events) at 1 year	1 year