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

NCT02523066 | Terminated DMC

• 1 other identifier: Magna Ease CN001
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mitral Valve or Aortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Mitral Valve or Aortic Valve Replancement

One-arm group

Device: Magna Ease

Interventions

Magna Ease DEVICE

This study is non-intervention

Mitral Valve or Aortic Valve Replancement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

The Chinese academy of medical sciences fuwai hospital cardiovascular disease

Beijing, Beijing Municipality, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 14, 2015
• Study Start: November 10, 2014
• Primary Completion: April 29, 2017
• Study Completion: May 7, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)