Cingularbio® Heart Valve Clincial Study

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

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

Study Overview

• Status: Completed
• Conditions: Diseases of Mitral and Aortic Valves
• Intervention / Treatment: Device: Cingularbio® Aortic valve replacement

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Cardiale Heelkunde
• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital of Fudan University
• Poland
  • Katowice, Poland
    • Klinika Kardiochirurgii
  • Kraków, Poland
    • Klinika Kardiochirurgii
  • Warszawa, Poland
    • Klinika Kardiochirurgii

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cingularbio® Heart valve; the patients will replaced by artificial heart valve	Device: Cingularbio® Aortic valve replacement; the patients will be replaced by Cingularbio heart valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device related adverse valve events	device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of procedural success	device implant success	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	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	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	1year
improvement in NYHA functional class	the NYHA score between baseline and 1 year	1year
mortality	the mortality rate at 1 year	1 year
structural valve deterioration	the SVD rate at 1 year	1 year
reoperation	the reoperation rate at 1 year	1 year
valve-related adverse events	all valve related AEs (not primary endpoint events) at 1 year	1 year

Collaborators and Investigators

• Sponsor: Shanghai Cingularbio Co. Ltd
• Investigators: Principal Investigator: chunsheng wang, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: April 24, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: XZBM-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: the publication will be started after study close out