NCT02400489

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2016

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2020

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

March 17, 2015

Last Update Submit

March 4, 2022

Conditions

Mitral Valve or Aortic Valve Replacement

Keywords

Heart Valve Replacement SurgeryPerimountEdwards

Outcome Measures

Primary Outcomes (2)

  • Twice echocardiography to evaluate the performance of heart valve

    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

    The subjects will be followed for the duration of one year after surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300051, China

Location

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

March 27, 2015

Study Start

September 25, 2014

Primary Completion

April 27, 2016

Study Completion

June 3, 2020

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be available to other researchers.

Locations

CN(3)