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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02400489

Enrollment

265

Registered

2015-03-27

Start date

2014-09-25

Completion date

2020-06-03

Last updated

2022-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve or Aortic Valve Replacement

Keywords

Heart Valve Replacement Surgery, Perimount, Edwards

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Twice echocardiography to evaluate the performance of heart valve	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
The recovery status of patients after surgery	The subjects will be followed for the duration of one year after surgery	—

Countries

China

Outcome results