Mitral Valve or Aortic Valve ReplacementNCT02400489
Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
An observational study of Mitral Valve or Aortic Valve Replacement, run by Edwards Lifesciences at 3 sites in China.
Trial summary
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China. To track the patients'situations during one year after surgery and to collect the relevant clinical data. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Valve or Aortic Valve Replacement
- How many people
- 265 participants
- Where
- 3 sitesChina
- Study dates
- 25 Sep 2014to 3 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients implanted with Perimount 6900PTFX or Perimount 2800TFX in three hospitals in China: Wuhan Asia Heart Hospital, Shandong Provincial Hospital, Tianjin Chest Hospital. Patients need to complete two follow up visits after surgery in hospitals.
Who may be able to join
- Patients implanted with Perimount 6900PTFX after 2012-11-19 or with Perimount 2800TFX after 2013-8-20
- Patients sign the Inform Consent Form (ICF) and agree to join the study
Who cannot join
- Don't have any specific exclusion criteria.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shandong Provincial Hospital
Jinan, Shandong, 250021
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
About this study
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China.
To track the patients'situations during one year after surgery and to collect the relevant clinical data.
- Conditions
- Mitral Valve or Aortic Valve Replacement
- Keywords
- Heart Valve Replacement Surgery, Perimount, Edwards
What is being measured
The primary outcome is the main question the study is designed to answer.
Twice echocardiography to evaluate the performance of heart valve
subjects need to do the echocardiography in two follow up visits
Measured: Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery
The recovery status of patients after surgery
Measured: The subjects will be followed for the duration of one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study start25 Sep 2014
- Primary completion27 Apr 2016
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve or Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xufa Chen, M.D, Principal investigator, Wuhan Asia Heart HospitalChengwei Zou, M.D, Principal investigator, Shandong Provincial HospitalNan Jiang, M.D, Principal investigator, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400489
- Sponsor's protocol ID
- Perimount CN001
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2015
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of Perimount Heart Valve in Chinese Patients
- ClinicalTrials.gov ID
- NCT02400489
- Acronym / sponsor ID
- Perimount CN001
- Conditions
- Mitral Valve or Aortic Valve Replacement
- Keywords
- Heart Valve Replacement Surgery, Perimount, Edwards
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2014 (actual)
- Primary completion
- 27 Apr 2016 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China.
To track the patients'situations during one year after surgery and to collect the relevant clinical data.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with Perimount 6900PTFX or Perimount 2800TFX in three hospitals in China: Wuhan Asia Heart Hospital, Shandong Provincial Hospital, Tianjin Chest Hospital. Patients need to complete two follow up visits after surgery in hospitals.
Key inclusion criteria (2 listed)
- Patients implanted with Perimount 6900PTFX after 2012-11-19 or with Perimount 2800TFX after 2013-8-20
- Patients sign the Inform Consent Form (ICF) and agree to join the study
Key exclusion criteria (1 listed)
- Don't have any 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.
Primary outcome
Twice echocardiography to evaluate the performance of heart valve
Time frame: Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery
subjects need to do the echocardiography in two follow up visits
The recovery status of patients after surgery
Time frame: The subjects will be followed for the duration of one year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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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.
Xufa Chen, M.D principal investigator
Wuhan Asia Heart Hospital
Chengwei Zou, M.D principal investigator
Shandong Provincial Hospital
Nan Jiang, M.D principal investigator
Tianjin Chest Hospital
3 sites 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 Lifesciences at 3 sites 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Twice echocardiography to evaluate the performance of heart valve (time frame: Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery). The study lists 2 primary outcomes in all. 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 18 Mar 2022.