NCT02755220

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

April 24, 2016

Last Update Submit

April 26, 2022

Conditions

Diseases of Mitral and Aortic Valves

Outcome Measures

Primary Outcomes (1)

  • device related adverse valve events

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

    12 month

Secondary Outcomes (9)

  • rate of procedural success

    post-operative

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

    1year

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

    1year

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

    1year

  • improvement in NYHA functional class

    1year

  • +4 more secondary outcomes

Study Arms (1)

Cingularbio® Heart valve

EXPERIMENTAL

the patients will replaced by artificial heart valve

Device: Cingularbio® Aortic valve replacement

Interventions

Cingularbio® Aortic valve replacementDEVICE

the patients will be replaced by Cingularbio heart valve

Cingularbio® Heart valve

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cardiale Heelkunde

Leuven, Belgium

Location

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Klinika Kardiochirurgii

Katowice, Poland

Location

Klinika Kardiochirurgii

Krakow, Poland

Location

Klinika Kardiochirurgii

Warsaw, Poland

Location

Study Officials

  • chunsheng wang

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2016

First Posted

April 28, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

April 1, 2019

Last Updated

April 28, 2022

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

the publication will be started after study close out

Locations

PL(3)BE(1)CN(1)