Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients

NCT ID: NCT02523066

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-10

Study Completion Date

2025-05-07

Brief Summary

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Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.

Detailed Description

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Conditions

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Mitral Valve or Aortic Valve Replacement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Mitral Valve or Aortic Valve Replancement

One-arm group

Magna Ease

Intervention Type DEVICE

This study is non-intervention

Interventions

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Magna Ease

This study is non-intervention

Intervention Type DEVICE

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Chinese academy of medical sciences fuwai hospital cardiovascular disease

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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Magna Ease CN001

Identifier Type: -

Identifier Source: org_study_id

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