Clinical Study to Evaluate the Performance of Magna Ease... | NCT02523066

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

NCT02523066

Sponsor

Edwards Lifesciences

Status

Terminated

Last Update Posted

May 18, 2025Actual

Enrollment

215Actual

Phase

Not provided

Conditions

Mitral Valve or Aortic Valve Replacement

Interventions

Magna Ease

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Nov 10, 2014Actual

Primary Completion Date

Apr 29, 2017Actual

Completion Date

May 7, 2025Actual

First Submitted Date

Aug 6, 2015

First Submission Date that Met QC Criteria

Aug 13, 2015

First Posted Date

Aug 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2025

Last Update Posted Date

May 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

215Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitral Valve or Aortic Valve Replancement		One-arm group	Device: Magna Ease

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magna Ease	Device	This study is non-intervention	Mitral Valve or Aortic Valve Replancement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Echocardiography to evaluate the performance of heart valve	Subjects are required to do eight times echocardiography in follow up visits	Up to five years after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patients who had the heart valves (Type: 7300TFX and 3300TFX), and are willing to participate in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Chinese academy of medical sciences fuwai hospital cardiovascular disease		Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided