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

NCT ID: NCT02400489

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

265 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-25

Study Completion Date

2020-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Valve or Aortic Valve Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xufa Chen, M.D

Role: PRINCIPAL_INVESTIGATOR

Wuhan Asia Heart Hospital

Chengwei Zou, M.D

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Hospital

Nan Jiang, M.D

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Site Status

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Perimount CN001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The China Mviv Registry
NCT05925335 UNKNOWN NA
Clinical Trial in China
NCT05580952 UNKNOWN NA