Mitral Valve or Aortic Valve ReplacementNCT02523066
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
An observational study of Mitral Valve or Aortic Valve Replacement, run by Edwards Lifesciences at 1 site in China.
Trial summary
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients. 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?
- Magna Ease
- Type of treatment
- Medical device
- How many people
- 215 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2014to 7 May 2025
- 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: The patients who had the heart valves (Type: 7300TFX and 3300TFX), and are willing to participate in the study.
Who may be able to join
- The patients who implanted with Magna Ease Heart Valve (Type:7300TFX and 3300TFX) in Fuwai Hospital in China.
- The patients agree to sign the inform consent form (ICF).
Who cannot join
- No specific exclusion criteria.
Trial locations and contacts
1 site in 1 country.
China1 site
The Chinese academy of medical sciences fuwai hospital cardiovascular disease
Beijing, Beijing Municipality
About this study
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.
- Conditions
- Mitral Valve or Aortic Valve Replacement
- Being tested
- Magna Ease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magna EaseDevice
This study is non-intervention
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve or Aortic Valve Replancement | One-arm group Receives: Device: Magna Ease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography to evaluate the performance of heart valve
Subjects are required to do eight times echocardiography in follow up visits
Measured: Up to five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study start10 Nov 2014
- Primary completion29 Apr 2017
- Study completion7 May 2025
Why it stopped: Sponsor decision
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
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523066
- Sponsor's protocol ID
- Magna Ease CN001
- Status last verified
- May 2025
- First submitted
- 6 Aug 2015
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
- ClinicalTrials.gov ID
- NCT02523066
- Acronym / sponsor ID
- Magna Ease CN001
- Conditions
- Mitral Valve or Aortic Valve Replacement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2014 (actual)
- Primary completion
- 29 Apr 2017 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 14 Aug 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.
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve or Aortic Valve Replancement | – | Device: Magna EaseOne-arm group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who had the heart valves (Type: 7300TFX and 3300TFX), and are willing to participate in the study.
Key inclusion criteria (2 listed)
- The patients who implanted with Magna Ease Heart Valve (Type:7300TFX and 3300TFX) in Fuwai Hospital in China.
- The patients agree to sign the inform consent form (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 |
|---|---|---|
| Magna EaseThis study is non-intervention | Device | Mitral Valve or Aortic Valve Replancement |
Primary outcome
Echocardiography to evaluate the performance of heart valve
Time frame: Up to five years after surgery
Subjects are required to do eight times echocardiography in follow up visits
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lifesciences 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: stopped early, as of the sponsor's last update on 18 May 2025. 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?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Echocardiography to evaluate the performance of heart valve (time frame: Up to five years after surgery). 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 May 2025.