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Cingularbio® Heart Valve Clincial Study

Primary Purpose

Diseases of Mitral and Aortic Valves

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cingularbio® Aortic valve replacement
Sponsored by
Shanghai Cingularbio Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diseases of Mitral and Aortic Valves

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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.

Sites / Locations

  • Cardiale Heelkunde
  • Zhongshan Hospital of Fudan University
  • Klinika Kardiochirurgii
  • Klinika Kardiochirurgii
  • Klinika Kardiochirurgii

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cingularbio® Heart valve

Arm Description

the patients will replaced by artificial heart valve

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2016
Last Updated
April 26, 2022
Sponsor
Shanghai Cingularbio Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02755220
Brief Title
Cingularbio® Heart Valve Clincial Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Cingularbio Co. Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diseases of Mitral and Aortic Valves

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cingularbio® Heart valve
Arm Type
Experimental
Arm Description
the patients will replaced by artificial heart valve
Intervention Type
Device
Intervention Name(s)
Cingularbio® Aortic valve replacement
Intervention Description
the patients will be replaced by Cingularbio heart valve
Primary Outcome Measure Information:
Title
device related adverse valve events
Description
device related events including Thromboembolism, Valve thrombosis,Major hemorrhage, Major paravalvular leak
Time Frame
12 month
Secondary Outcome Measure Information:
Title
rate of procedural success
Description
device implant success
Time Frame
post-operative
Title
the difference between baseline and 1 year in Effective orifice area (EOA)
Description
the difference between baseline and 1 year in Effective orifice area (EOA) in echocardiographic hemodynamic
Time Frame
1year
Title
the difference between baseline and 1 year in pressure gradient (PG)
Description
the difference between baseline and 1 year in pressure gradient (PG) in echocardiographic hemodynamic
Time Frame
1year
Title
the difference between baseline and 1 year in Peak aortic valve velocity
Description
the difference between baseline and 1 year in Peak aortic valve velocity in echocardiographic hemodynamic
Time Frame
1year
Title
improvement in NYHA functional class
Description
the NYHA score between baseline and 1 year
Time Frame
1year
Title
mortality
Description
the mortality rate at 1 year
Time Frame
1 year
Title
structural valve deterioration
Description
the SVD rate at 1 year
Time Frame
1 year
Title
reoperation
Description
the reoperation rate at 1 year
Time Frame
1 year
Title
valve-related adverse events
Description
all valve related AEs (not primary endpoint events) at 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chunsheng wang
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiale Heelkunde
City
Leuven
Country
Belgium
Facility Name
Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Klinika Kardiochirurgii
City
Katowice
Country
Poland
Facility Name
Klinika Kardiochirurgii
City
Kraków
Country
Poland
Facility Name
Klinika Kardiochirurgii
City
Warszawa
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
the publication will be started after study close out

Learn more about this trial

Cingularbio® Heart Valve Clincial Study

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