Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
Sponsor
Edwards Lifesciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02523066
Collaborator
(none)
215
1
96.7
2.2
Study Details
Study Description
Brief Summary
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
215 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients
Actual Study Start Date
:
Nov 10, 2014
Actual Primary Completion Date
:
Apr 29, 2017
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Mitral Valve or Aortic Valve Replancement One-arm group |
Device: Magna Ease
This study is non-intervention
|
Outcome Measures
Primary Outcome Measures
- Echocardiography to evaluate the performance of heart valve [Up to five years after surgery]
Subjects are required to do eight times echocardiography in follow up visits
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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).
Exclusion Criteria:
- No specific exclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Chinese academy of medical sciences fuwai hospital cardiovascular disease | Beijing | Beijing | China |
Sponsors and Collaborators
- Edwards Lifesciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT02523066
Other Study ID Numbers:
- Magna Ease CN001
First Posted:
Aug 14, 2015
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No