Mitral Valve or Aortic Valve ReplacementNCT02381678
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
An observational study of Mitral Valve or Aortic Valve Replacement, run by Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve or Aortic Valve Replacement
- What is being tested?
- Perimount 2900/6900 Heart Valve
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Jan 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who had the Perimount Heart Valve (Type: 6900P and 2900) Replacement Surgery during 2001-2007 in Guangdong General Hospital in China
Who may be able to join
- 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
Who cannot join
- No specific exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mitral Valve or Aortic Valve Replacement
- Being tested
- Perimount 2900/6900 Heart Valve
- Keywords
- Heart Valve Replacement, Perimount 2900, China, Perimount 6900P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perimount 2900/6900 Heart ValveDevice
This is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Perimount 2900/6900 Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7-15 years after heart valve replacement surgery (during 2001-2007)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mitral Valve or Aortic Valve ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huiming Guo, M.D, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381678
- Sponsor's protocol ID
- Edwards-CN-001
- Status last verified
- May 2016
- First submitted
- 5 Mar 2015
- Last updated
- 17 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007
- ClinicalTrials.gov ID
- NCT02381678
- Acronym / sponsor ID
- Edwards-CN-001
- Conditions
- Mitral Valve or Aortic Valve Replacement
- Keywords
- Heart Valve Replacement, Perimount 2900, China, Perimount 6900P
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Posted 17 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects implanted with Perimount Heart Valve | – | Device: Perimount 2900/6900 Heart ValveOnly one group was set for this study, including all enrolled subjects who implanted with Perimount Heart Valve during 2001 to 2007 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who had the Perimount Heart Valve (Type: 6900P and 2900) Replacement Surgery during 2001-2007 in Guangdong General Hospital in China
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- No specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perimount 2900/6900 Heart ValveThis is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit. | Device | Subjects implanted with Perimount Heart Valve |
Primary outcome
The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography
Time frame: 7-15 years after heart valve replacement surgery (during 2001-2007)
This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Mitral Valve or Aortic Valve Replacement
Not yet recruitingPhase 3
Apixaban VS Warfarin in AF Pts First Three Months After Repair or BIO AVR MVR
Valve Disease, Heart, Atrial Fibrillation (AF)
Not yet recruitingObservational study
Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement
Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiming Guo, M.D principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve or Aortic Valve Replacement, run by Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography (time frame: 7-15 years after heart valve replacement surgery (during 2001-2007)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.