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

March 4, 2022 updated by: Edwards Lifesciences

To recruit patients who implanted with Perimount Heart Valve (Type Number: 6900PTFX or 2800TFX) from three hospitals in China.

To track the patients'situations during one year after surgery and to collect the relevant clinical data.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Asia Heart Hospital
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300051
        • Tianjin Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients implanted with Perimount 6900PTFX or Perimount 2800TFX in three hospitals in China: Wuhan Asia Heart Hospital, Shandong Provincial Hospital, Tianjin Chest Hospital.

Patients need to complete two follow up visits after surgery in hospitals.

Description

Inclusion Criteria:

  • Patients implanted with Perimount 6900PTFX after 2012-11-19 or with Perimount 2800TFX after 2013-8-20
  • Patients sign the Inform Consent Form (ICF) and agree to join the study

Exclusion Criteria:

  • Don't have any specific exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Twice echocardiography to evaluate the performance of heart valve
Time Frame: Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery
subjects need to do the echocardiography in two follow up visits
Compare the 1st echocardiography at average 6 months after surgery and 2nd echocardiography at 12 months after surgery
The recovery status of patients after surgery
Time Frame: The subjects will be followed for the duration of one year after surgery
The subjects will be followed for the duration of one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Xufa Chen, M.D, Wuhan Asia Heart Hospital
  • Principal Investigator: Chengwei Zou, M.D, Shandong Provincial Hospital
  • Principal Investigator: Nan Jiang, M.D, Tianjin Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2014

Primary Completion (Actual)

April 27, 2016

Study Completion (Actual)

June 3, 2020

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Perimount CN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to other researchers.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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