A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
1 other identifier
observational
225
1 country
1
Brief Summary
The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the patients' post-operation infomation including the current living status, mortality rate, and the possibility of re-operation，bleeding and thrombosis. This is a retrospective , observentional clinical study to be conducted in Guangdong General Hospital in China. This study will enroll up to 200 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
October 17, 2016
CompletedOctober 17, 2016
May 1, 2016
1.5 years
March 5, 2015
May 26, 2016
August 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography
This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography
7-15 years after heart valve replacement surgery (during 2001-2007)
Study Arms (1)
Subjects implanted with Perimount Heart Valve
Only one group was set for this study, including all enrolled subjects who implanted with Perimount Heart Valve during 2001 to 2007
Interventions
This is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit.
Eligibility Criteria
The patients who had the Perimount Heart Valve (Type: 6900P and 2900) Replacement Surgery during 2001-2007 in Guangdong General Hospital in China
You may qualify if:
- The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China
- The patients agree to join the study and sign the ICF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong General Hospital
Guangzhou, Guangdong, 510120, China
Results Point of Contact
- Title
- Dr. Huiming Guo (Chief in Cardiac Surgical Department)
- Organization
- Guangdong General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Huiming Guo, M.D
Guangdong Provincial People's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 6, 2015
Study Start
May 1, 2014
Primary Completion
November 1, 2015
Study Completion
January 1, 2016
Last Updated
October 17, 2016
Results First Posted
October 17, 2016
Record last verified: 2016-05